BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE

    MDR report key: 2874138 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01581
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE (B)(4) DRIVER HAS A BROKEN TIP AND IS TWISTED IN A WAY THAT CORRESPONDS TO THE CLOCKWISE ROTATION OF INSERTION. THE LOADING WHICH OCCURRED WHILE USING THIS DRIVER EXCEEDED THE TORSIONAL STRENGTH OF THE DRIVER TIP. IT IS POSSIBLE THAT THIS INSTRUMENT WAS USED IN VERY HARD BONE WITHOUT ADEQUATE HOLE PREPARATION USING THE AWL; IT IS NOT KNOWN HOW MUCH FORCE WAS USED TO INSERT THIS SCREW. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ONGOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. DEVICE HISTORY RECORDS SHOWED THAT NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS IS 1 OF TWO REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE OF THE SPINAL CONSTRUCT OF T10-PELVIS, AN APPROXIMATELY 4MM SCREWDRIVER SHAFT TIP BROKE OFF AND REMAINED INSERTED INSIDE THE IMPLANTED SCREW HEAD AT L5. SUBSEQUENTLY, THE SCREW AND BROKEN SCREWDRIVER TIP WAS EXPLANTED AND A NEW REPLACEMENT SCREW IMPLANT AND REPLACEMENT SCREWDRIVER WAS USED. NO FRAGMENTS OF THE BROKEN SCREWDRIVER WERE REPORTED IN THE OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE BIHEXAGONAL SCREWDRIVER HWC SYNTHES GMBH 7645012

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR POLYAXIAL SCREW