BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3®

    MDR report key: 3932234 · Received July 14, 2014

    Report

    Report Number
    0009610622-2014-00331
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION REVEALED THE TARGET DEVICE AND THE SPEEDLOCK SLEEVE TO BE THE SUBJECT PRODUCTS. ALL OTHER INSTRUMENTS REPORTED ARE CONSIDERED CONCOMITANT PRODUCTS. REVIEW OF THE INSPECTION RECORDS OF THE RETURNED TARGET DEVICE AND THE SPEEDLOCK SLEEVE REVEALED NO DISCREPANCIES. A SIMULATION OF THE PRE-OPERATIVE FUNCTION TEST (AS REQUIRED PER IFU) WAS PERFORMED ON THE RETURNED TARGET DEVICE, SPEEDLOCK SLEEVE, TISSUE PROTECTION SLEEVE AND DRILL SLEEVE WITH SAMPLE DEVICES IN ORDER TO REPRODUCE THE REPORTED EVENT. THE TEST SET UP WAS COMPLETED WITH A SAMPLE GAMMA3 TROCHANTERIC NAIL AND THE CORRESPONDING DRILLS AND DRILL SLEEVE. THE TEST REVEALED THAT FUNCTION IS FULLY GIVEN ON ALL DEVICES. THE DRILLS PASSED THE CORRESPONDING DRILL HOLES WITHOUT CONTACT TO THE NAIL; NO DEVIATION WAS FOUND. AN ADDITIONAL TARGET DEVICE FUNCTIONAL TEST PERFORMED ON THE ORIGINAL FUNCTION TEST DEVICE REVEALED THAT THE TEST PINS PASSED ALL OF THE HOLES OF THE DEVICE WITHOUT CONTACT, AS WELL; NO DEVIATION WAS FOUND. THE REPORTED EVENT COULD NOT BE REPRODUCED. BASED ON THE ABOVE OBSERVATIONS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE(S). HOWEVER, THE ACTUAL CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION GIVEN. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GAMMA3 TARGETING DEVICE DID NOT ALLOW THE DISTAL SCREW TO ALIGN WITH THE CORRECT POSITION IN THE DYNAMIC DISTAL LOCKING POSITION OF THE GAMMA3 TROCHANTERIC NAIL. THE GUIDE CONTINUALLY AIMED POSTERIOR TO THE NAIL HOLE AND DID NOT FUNCTION ADEQUATELY. THIS ADDED 15+ MINUTES TO THE TOTAL TIME ALTHOUGH NO IMMEDIATE HARM APPEARED TO BE DONE TO THE PATIENT. THE PATIENT IS REPORTED TO BE 92 YRS OLD MALE WITH RIGHT SIDE INTER TROCHANTERIC FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GAMMA3 TARGETING DEVICE DID NOT ALLOW THE DISTAL SCREW TO ALIGN WITH THE CORRECT POSITION IN THE DYNAMIC DISTAL LOCKING POSITION OF THE GAMMA3 TROCHANTERIC NAIL. THE GUIDE CONTINUALLY AIMED POSTERIOR TO THE NAIL HOLE AND DID NOT FUNCTION ADEQUATELY. THIS ADDED 15+ MINUTES TO THE TOTAL TIME ALTHOUGH NO IMMEDIATE HARM APPEARED TO BE DONE TO THE PATIENT. THE PATIENT IS REPORTED TO BE (B)(6) MALE WITH RIGHT SIDE INTER TROCHANTERIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410866 TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL KME905495

    Patients

    Seq Age Sex Outcome Treatment
    1 Other