BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS SELF-CENTER SOFTLO

    MDR report key: 3131686 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02897
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    December 28, 2010
    Manufacturer
    SYNTHES USA
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. (B)(6). THE INVESTIGATION OF THE COMPLAINED BONE HOLDING FORCEPS SHOWS, THAT THE TOOTH OF THE LOCKING CAP OF THE SOFT LOCKING SYSTEM IS BROKEN OFF. THE REPORTED BREAKAGE IS INDICATIVE OF THE LOCKING CAP NOT PROPERLY ALIGNED WITH THE TOOTHED RACK AND POSSIBLY AT THE SAME TIME THE FORCEPS IS UNDER TENSION SUDDENLY UNBURDENED WITHOUT BACKPRESSURE ON THE HANDHOLDS. THE EXACT CAUSE OF THE REPORTED PROBLEM IS UNDETERMINED, BUT THE LOCKING MECHANISM DELICATE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PLACEHOLDER.

    Description of Event or Problem · 1

    DEFECTIVE FORCEPS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236071 BONE HOLDING FORCEPS SELF-CENTER SOFTLO HTD SYNTHES USA 5018035

    Patients

    Seq Age Sex Outcome Treatment
    1