BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW

    MDR report key: 2907322 · Received January 10, 2013

    Report

    Report Number
    8030965-2012-01499
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART WAS MANUFACTURED IN 2004 AT SMALL BONE INNOVATIONS. (B)(4) MADE THIS PART THE FIRST TIME IN 2007. DEVICE HAS NOT BEEN RETURNED, NO CONCLUSIONS CAN BE MADE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. DATE DEVICE RECEIVED FOR EVALUATION. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    DURING AN INTERIOR CERVICAL PROCEDURE: USING A SELF RETAINING SCREWDRIVER SURGEON WAS PLACING THE LOCKING CAPS AND THE SCREWDRIVER BROKE INTO TWO PIECES. DRIVER BROKE ONE THIRD UP FROM THE BOTTOM AND THE BREAK WAS CLEAN WITH NO FRAGMENTS. THE PIECES WERE RETRIEVED AND SURGEON SELECTED ANOTHER DRIVER. ALSO DURING THE PROCEDURE; SURGEON WAS USING THE COUNTER TORQUE WRENCH AND TWO OF THE FOUR PRONGS BROKE, DROPPING INTO THE WOUND. THE PIECES OF THE WRENCH WERE RETRIEVED. ANOTHER WRENCH WAS SELECTED AND THE PROCEDURE WAS COMPLETED. SURGEON VERIFIED NO PIECES LEFT IN THE PATIENT BY X-RAY. THERE WAS A MINUTE OR TWO DELAY IN THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13612 SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW SELF-RETAINING SCREWDRIVER HWC SYNTHES GMBH 8571

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR COUNTER TORQUE WRENCH| SCREWDRIVER