BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST INTERTROCHANTERIC ONE-PIECE NAIL CAP

    MDR report key: 2053468 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00470
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    November 18, 2010
    Report Date
    January 31, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AS RETURNED, THE NAIL CAP HAS SCRATCHES NOTED CIRCUMFERENTIALLY AROUND TIP AND DAMAGE IN THREAD PORTION. SURGICAL TECHNIQUE USED IS UNK. ONE OF THE PROBABLE CAUSE COULD BE THAT THE NAIL CAP MAY NOT HAVE BEEN PROPERLY TIGHTENED INTO THE NAIL; HOWEVER, THIS CANNOT BE CONFIRMED WITH AVAILABLE INFO. THERE IS INSUFFICIENT INFO PROVIDED TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON COULD NOT LOCK THE ITST NAIL CAP TO THE END AND USED ANOTHER ONE. SURGERY WAS DELAYED BY 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITST INTERTROCHANTERIC ONE-PIECE NAIL CAP HSB ZIMMER, INC. 61497377

    Patients

    Seq Age Sex Outcome Treatment
    1