BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION INSERTER LINK

    MDR report key: 1113318 · Received August 12, 2008

    Report

    Report Number
    1822565-2008-00511
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    June 21, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE HAS A POTENTIAL USAGE PERIOD OF 5 YEARS AND THE THREADS MAY HAVE BECOME WORN DUE TO HEAVY USE. THE INSTRUMENT COULD ALSO FRACTURE IF CROSS THREADED OR NOT FULLY FASTENED IN THE LAG SCREW. THE DIMENSIONAL AND HARDNESS SPECIFICATIONS ARE CONFORMING TO PRINT. USER OR IATROGENIC FAILURE COULD BE THE PROBABLE REASON FOR THIS EVENT. THE DEVICE IS FRACTURED AT THE FIRST THREAD INITIATING AT THE SMOOTH SHAFT. WEAR DAMAGE ON THE KNURLING AND THE REST OF THE SHAFT IS CONSISTENT WITH THE APPROXIMATELY 5 YEAR POTENTIAL FIELD AGE OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THERE IS NO INDICATION THAT DESIGN OR MANUFACTURE CONTRIBUTED TO THIS OUTCOME. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE SURGEON WAS REMOVING INSERTER LINK FROM LAG SCREW, THE THREAD OF INSERTER LINK WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION INSERTER LINK TRAUMA INSTRUMENT LXH ZIMMER, INC. NA 60079453

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK