BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM DCP HIP DRILL NEUTRAL & LOAD 60MM

    MDR report key: 3003640 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10434
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 3, 2011
    Report Date
    June 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR INVESTIGATION. THE SLEEVE WAS NOT HOLDING IN THE DRILL GUIDE. VISUAL INSPECTION SHOWED THAT THE RETENTION BALL FELL OUT OF ITS SEAT AND WAS MISSING. DUE TO THE MISSING PART, THE EVALUATION COULD NOT BE COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETENTION PIN FELL OUT. THE PART NO LONGER HOLDS IN THE DRILL GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88130 4.5MM DCP HIP DRILL NEUTRAL & LOAD 60MM FZX SYNTHES GMBH 3712816

    Patients

    Seq Age Sex Outcome Treatment
    1