BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 FEMUR

    MDR report key: 3132219 · Received May 29, 2013

    Report

    Report Number
    0009610622-2013-00289
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT WAS NOT CONFIRMED AS THE FUNCTIONAL TEST PERFORMED DURING INVESTIGATION REVEALED ALL RETURNED DEVICES BEING FULLY FUNCTIONAL AND AS DECREASED TARGETING ACCURACY COULD NOT BE VERIFIED. DEVIATIONS IN THE INSPECTION RECORDS OF BOTH NAIL HANDLE AND TARGETING ARM, WERE NOT FOUND. A CHECK OF THE FUNCTION ON 100% OF THE DEVICES (SUB-SUPPLIER) AND ADDITIONAL IN-HOUSE SPOT CHECK OF THE LOT IN QUESTION REVEALED FUNCTION WAS GIVEN IN FULL ON THE DEVICES AT THE STAGE OF DELIVERY. AS BOTH INSTRUMENTS HAD BEEN IN USE FOR A LONGER TIME (BOTH MANUFACTURED IN 2004) WE PRE-SUPPOSE THAT THE DEVICES HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. THUS, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A PROCEDURE THERE WAS AN ISSUE WITH THE T2 JIG. THE SALES REP REPORTED THAT THE CUSTOMER ASSEMBLED THE JIG AND HE ASKED THEM TO CHECK THAT IT ALL LINED UP CORRECTLY, THE SALES REP REPORTED THAT IT WAS. THE SALES REP REPORTED THAT THE CUSTOMER TOOK A LATERAL AFTER THE JIG WAS REMOVED. THE SALES REP REPORTED THAT THIS LATERAL SHOWED THAT THE SCREW IN THE DYNAMIC HOLE HAD MISSED THE NAIL. THE SALES REP REPORTED THAT THE CUSTOMER REMOVED THE SCREW AND CALLED THE CLINICAL DIRECTOR WHO TOLD THE REGISTRAR THAT HE COULD CLOSE AS ONE SCREW WOULD BE ENOUGH. THE REMOVED SCREW WAS DISCARDED BUT THE SALES REP HAS THE JIG FOR INVESTIGATION. THE SALES REP REPORTED THAT NO ADVERSE CONSEQUENCE WERE REPORTED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A PROCEDURE, THERE WAS AN ISSUE WITH THE T2 JIG. THE SALES REP REPORTED THAT THE CUSTOMER ASSEMBLED THE JIG AND HE ASKED THEM TO CHECK THAT IT ALL LINED UP CORRECTLY, THE SALES REP REPORTED THAT IT WAS. THE SALES REP REPORTED THAT THE CUSTOMER TOOK A LATERAL AFTER THE JIG WAS REMOVED. THE SALES REP REPORTED THAT THIS LATERAL SHOWED THAT THE SCREW IN THE DYNAMIC HOLE HAD MISSED THE NAIL. THE SALES REP REPORTED THAT THE CUSTOMER REMOVED THE SCREW AND CALLED THE CLINICAL DIRECTOR WHO TOLD THE REGISTRAR THAT HE COULD CLOSE AS ONE SCREW WOULD BE ENOUGH. THE REMOVED SCREW WAS DISCARDED BUT THE SALES REP HAS THE JIG FOR INVESTIGATION. THE SALES REP REPORTED THAT NO ADVERSE CONSEQUENCE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235226 NAIL HANDLE T2 FEMUR INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL KP215457

    Patients

    Seq Age Sex Outcome Treatment
    1 Other