call 866.979.TOBY (8629)

INSTRUCTIONS FOR USE – DOWNLOAD THIS DOCUMENT AS A PDF FILE

WOLF® Long Bone Plate System

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY

There is no express or implied warranty, including any implied warranty of merchantability or fitness for a particular purpose, on Toby Orthopaedics’ product(s) described in this publication. Under no circumstances shall Toby Orthopaedics be liable for any direct, incidental, or consequential damages other than as expressly provided by law. No person has the authority to bind Toby Orthopaedics to any representation or warranty except as specifically set forth herein.

Descriptions or specifications in Toby Orthopaedics printed matter, including this publication, are meant solely to generally describe the product at the time of manufacture and do not constitute any express or implied warranties.

WOLF-instructions-1-nomenclatureINDICATIONS

The WOLF® Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses.

CONTRAINDICATIONS

  • Diaphysis fractures with significant fragmentation where reconstruction is not possible.
  • Open diaphysis fractures with severe contamination.

DESCRIPTION

The WOLF® system contains bone plates for the repair of fractures of the humerus, radius, and ulna.  Included in the system are various screws, pegs, plates, k-wires, drill bits, and specialized instruments. All components and specialized instruments, which may be purchased independently, are supplied either in a non-sterile container suitable for moist heat sterilization or individual sterile packages.

MATERIAL SPECIFICATION

WOLF® implantable components are made of Titanium alloy Ti-6AL-4V ELI.  This material meets the requirements of ASTM Designation F136-02a, Standard Specification for Wrought Titanium – 6 Aluminum – 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The WOLF® implantable components have not been evaluated for safety / compatibility in an MRI environment.

STERILIZATION

WOLF® system components are supplied sterile and non-sterile. Products provided in sterile packages were exposed to a minimum dose of 25.0-kGy gamma irradiation.  Resterilization of a sterile device may only be performed if the original sterile package was opened in error, and resterilization shall only be accomplished using the moist heat sterilization cycle provided below or an equivalent approved sterilization cycle.

All non-sterile components are intended to be moist heat sterilized at the health-care facility.  Prior to use, the product shall be inspected for any signs of damage, tampering, or contamination.  Any component suspected of damage should be replaced prior to use. If the tray is deemed satisfactory, it should be wrapped in a 510(k)-approved wrap and sterilized following the Dynamic-Air-Removal moist heat sterilization process identified in the table below, or an equivalent sterilization cycle validated for this type of product.  The use of flash sterilization is not recommended for WOLF®.

PANTERA-instructions-2-table

Any method of moist heat sterilization used should be validated in accordance with the current revision of the following standards to demonstrate a sterility assurance level (SAL) of 10-6 or better:  ISO 17664, AAMI TIR 12, AAMI TIR 30, AAMI ST 79, AAMI ST 81.

WOLF® SYSTEM STORAGE AND INSTRUMENT USE INSTRUCTIONS

The WOLF® Plate system should be stored in a cool dry place away from direct sunlight.  Prior to use, inspect the product packaging for any signs of damage, tampering, or contamination.  Use oldest products first.  Instrumentation should be disassembled for cleaning and inspection where appropriate (Refer to Doc 50000133).  Refer to the WOLF® Surgical Technique Guide for detailed instrumentation usage instructions (Refer to Doc 50000132).

PRECAUTIONS

  • WOLF® instrumentation does not have an infinite functional life.  Because the instrumentation is subjected to repeated stresses related to impaction, bone contact, routine cleaning, and sterilization processes, all re-usable instrumentation should be carefully inspected before each use to ensure that they are fully functional.  Scratches and/or dents may result in breakage during use.  Dullness of cutting edges can result in poor functionality.  All damaged instrumentation and those suspect to not perform as required should be replaced to prevent any potential patient injury such as metal fragments falling into the surgical site.  Care should be taken to remove any debris, tissue or bone fragments that may collect on the instruments.  It is important that the surgeon and operating theater staff be fully conversant with the appropriate surgical technique for the WOLF® system.
  • All implantable devices must never be reused.  Previous stresses from prior use may cause imperfections that can potentially lead to device failure.  All implantable devices should be protected from scratches, nicking, or dents that may lead to stress concentrations that would potentially result in failure.
  • The patient shall be cautioned, preferably in writing, about the use, limitations, and possible adverse effects of this device.
  • Exercise caution to avoid damaging the vasculature of the bone fragments.
  • Use caution to match the thickness of the plate to the bone size in question, taking into account the size of the defect needing repair.  Lower profile plates should not be used in larger bones or larger patients.  Where used, hardware failure may occur and may require revision surgery.  The low profile plates are preferable for use on small bones.  The use of a thicker plate in a small bone can lead to hardware irritation.  The patient may request hardware removal after fracture healing in such cases.
  • When using K-wires to affix the plate to the bone, use only sharp K-wires and irrigation to avoid local burn injury to the bone.
  • Use a drill guide whenever using a drill bit to minimize potential injury to the surrounding tissue.
  • Use caution to match the use of drill bits and corresponding screws to ensure optimal fixation.
  • Exercise caution to ensure that the long drill guide (66mm) is installed on the plate and used in combination when measuring with the extended depth gauge.  Failure to do this will result in incorrect measurements.  Note: measuring instruments have ± 1mm accuracy.
  • Avoid drilling past the far cortex; the drill bit can produce significant soft tissue damage.
  • Exercise caution to avoid creating a cortical defect when the incorrect side of the dual locking screw is used.
  • Ensure that a bypass screw / peg is installed first into the dual divergent screw hole if an additional locking screw / peg is to be installed into the adjacent hole.  Failure to use a bypass screw or failure to properly align the bypass screw head will result in difficulty with installation of the secondary screw / peg.
  • During hardware removal, never try to remove the bypass fastener first; it may be impossible to remove and the surgeon risks stripping the head of the screw.  The color-coding on the fasteners should aid in the proper identification of a bypass fastener (light pink / purple) and a fully headed fastener (light green / dark green).
  • Do not use fasteners other than those provided within the WOLF® system. Such usage may result in device failure and/or corrosion.
  • Use caution to ensure sufficient bone stock is available to use dual divergent fixation, especially in smaller bones, to avoid creating cortical defects, and when choosing fasteners, as the dual divergent feature is not recommended for locking screw diameters larger than 2.7mm.
  • Devices may fail when subjected to increased loading associated with delayed union or nonunion.
  • The WOLF® system has not been evaluated for safety and compatibility in the MR environment and the WOLF® system has not been tested for heating or migration in the MR environment.

ADVERSE EFFECTS

Potential complications/adverse events associated with the use of implantable bone plates include, but are not limited to, the following:

  • Postoperative pain and/or discomfort
  • Prominent screws
  • Hardware failure
  • Numbness
  • Inflammation
  • Failure of fracture healing
  • General infection

factory-iconToby Orthopaedics, Inc.
401 SW 42nd Ave, Suite 200,
Miami, FL 33134  USA
Phone: 866.979.8629

 

ec-rep-iconAtlantico Systems LTD
34 Oldfield Kingston
Galway, Ireland
Phone: +35 391443609

FTRT-instructions-3-no-second-useNote:  WOLF® Implantable components are Single Use Only. Do not re-use.
Caution:  Re-using Implantable Components may result in an increase risk for infection.  

For implantation instructions and guidance, refer to the
WOLF® Surgical Technique Guide (50000132)

ce-icon0086

Contact Us

Toby Orthopaedics, Inc.

Domestic Toll-free:
866.979.TOBY (8629)
Office: 305.665.8699
Fax: 305.768.0269

sales@TobyOrtho.com