BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD HOLDING FORCEPS FOR 6.0MM RODS

    MDR report key: 2974372 · Received February 22, 2013

    Report

    Report Number
    8030965-2013-00586
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE FORCEPS WERE RECEIVED WITH SOME MINOR SCRATCHES ON THE SURFACE. THE SPIKES LOCATED IN THE FUNCTIONAL END OF BOTH FORCEPS MAY BE WORN FROM USE. BOTH FORCEPS ARE FROM LOTS THAT WERE MANUFACTURED OVER 10 YEARS AGO. CHU ENGINEER WAS UNABLE TO PASS A 4.99 AND 5.01 GAGE PIN THRU THE FORCEPS WHICH CORRESPONDS TO THE DESIGN SPECIFICATION ON THE DRAWING. A 5MM MAXIMUM DISTANCE BETWEEN THE SPIKES IS CALLED OUT ON THE DRAWING FOR THESE FORCEPS. IN ADDITION, THE COMPLAINT INVOLVES USING THESE WITH THE MATRIX SYSTEM AND THESE ARE NOT TO BE USED WITH MATRIX.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE DEVICE HISTORY RECORD IS NOT AVAILABLE ANYMORE FOR REVIEW AS THE DEVICE IS OVER 11 YEARS OLD. THEREFORE WE CONCLUDE THIS COMPLAINT TO BE INDETERMINATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A SURGEON REPORTED WHILE USING ROD HOLDING FORCEPS TO PERFORM ROTATION OF THE ROD; THE ROD HOLDERS WOULD SLIP ON THE ROD AND NOT GRIP HARD ENOUGH. THE SLIPPAGE WOULD NOT ALLOW HIM TO ROTATE THE ROD TO HIS SATISFACTION, SO MAXIMUM CORRECTION WAS NOT ACHIEVED. THIS ADDED 15 MINUTES TO THE SURGERY AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78904 ROD HOLDING FORCEPS FOR 6.0MM RODS FORCEPS HTD SYNTHES GMBH A7KA20

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR