BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/ TROCHANTERIC FIXATION NAILS

    MDR report key: 2945414 · Received February 1, 2013

    Report

    Report Number
    2530088-2013-10019
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL EVALUATION REVEALED THE DEVICE WAS RETURNED WITH SIGNIFICANT DENTS AND SCRATCHES. THERE ARE SEVERAL DEEP DENTS AND SCRATCHES ON TOP AND EDGES OF THE DEVICE INDICATING MISUSE. THE TANG FEATURE IS DENTED AND MIS-SHAPED. THE UNDERSIZED LOCATION HOLE WOULD NOT CAUSE THE COMPLAINT CONDITION BECAUSE THE DEVICES COULD BE ASSEMBLED WITHOUT DIFFICULTY. THE REMAINING FEATURE OF SIZE WERE MEASURED AND FOUND WITHIN PRINT SPECIFICATION. THE BOSS FAILS THE POSITION TEST INDICATING SOMETHING IS NOT ALIGNING PROPERLY. IT IS UNKNOWN IF THIS DEVICE FAILS THE FUNCTION BECAUSE OF MANUFACTURING OR AS A RESULT OF THE ABUSE. BASED ON THE CONDITION THAT REPORTED EVENT AND THE CONDITION OF THE RETURNED DEVICE, THE CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE INSERTION HANDLE TO PUT THE BLADE THROUGH THE TROCHANTER FIXATION NAIL (TFN), BUT IT WOULD NOT LINE UP. FINALLY HE WAS ABLE TO PUT IT THROUGH, BUT IT DID NOT ALIGN WITH THE DISTAL HOLE. THE SURGEON COULD NOT PUT A DISTAL LOCKING SCREW IN THE TFN. THE PROCEDURE WAS COMPLETED WITHOUT PLACING A LOCKING SCREW. INSERTION HANDLE IS OLD AND MOST LIKELY DEFORMED BY MULTIPLE SURGEONS, WHO USED IT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44733 INSERTION HANDLE F/ TROCHANTERIC FIXATION NAILS FZX SYNTHES (USA) 4595555

    Patients

    Seq Age Sex Outcome Treatment
    1