BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP F/EXT-FIX F/DIST RAD

    MDR report key: 2823007 · Received November 7, 2012

    Report

    Report Number
    2530088-2012-00973
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KTT
    PMA / PMN Number
    K090658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PATIENT WAS BEING TREATED FOR A DISTAL RADIUS FRACTURE. WHILE THE DOCTOR WAS CLAMPING THE SECURING CLAMP ROD SCREW ON THE METACARPAL, THE SCREW DID NOT ROTATE CLOCKWISE AND ANTICLOCKWISE DIRECTION. WHEN THE DOCTOR APPLIED MORE POWERFUL FORCE TO THE OFFSET WRENCH, THE DRIVER TIP OF THE OFFSET WRENCH WAS BROKEN AS IT WAS CONNECTING TO THE CLAMP. THE CLAMP DID NOT WORK FUNCTIONALLY. THE SURGEON REPLACED THE CLAMP WITH A COMPETITORS CLAMP TO COMPLETE THE PROCEDURE. THIS REPORT IS #2 OF 3 FOR THE SAME EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAMP F/EXT-FIX F/DIST RAD CLAMP F/EXT-FIX F/DIST RAD KTT SYNTHES BRANDYWINE 6790242

    Patients

    Seq Age Sex Outcome Treatment
    1 WRENCH, ROD