BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION STANDARD LOCKING BOLT

    MDR report key: 1214112 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00734
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS REPORTED THE LOCKING BOLT IS CLEARLY CROSS THREADED TO THE ITST NAIL PROBABLY DUE TO MISALIGNMENT OF THE 2 MATING COMPONENTS DURING INSERTION. THE THREAD PARAMETERS OF NAIL ARE INTACT AND CONFORMING TO SPECIFICATIONS BUT LOT NUMBER INFO ON THE LOCKING BOLT IS NOT AVAILABLE FOR ANALYSIS. THE PROPER PROCEDURE IS TO ALIGN THE NAIL WITH THE TARGETING GUIDE JAWS FIRMLY AND THEN THREAD THE LOCKING BOLT WITH THE ETCH ARROW ON THE NAIL MATCHING WITH THE TARGETING GUIDE. IT APPEARS THAT THE REPORTED CONDITION IS PROBABLY DUE TO USER ERROR. EVALUATION: LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGERY WAS DELAYED FOR 1/2 HOUR WHEN THE NAIL WAS OPENED AND PLACED INTO GUIDE WITH LOCKING BOLT. SCRUB NURSE ATTEMPTED TO TIGHTEN LOCKING BOLT AND IN THE PROCESS OF DOING SO, CROSS-THREADED THE BOLT INTO THE NAIL-FIXATING THE NAIL TO THE GUIDE WHERE BOTH SCRUB NURSE AND DOCTOR WERE UNABLE TO LOOSEN THE BOLT FROM THE NAIL/GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION STANDARD LOCKING BOLT TRAUMA INSTRUMENT HTN ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK