BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 3930141 · Received July 11, 2014

    Report

    Report Number
    2530088-2014-10181
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT HIP, THE SCREWDRIVER TIP BROKE IN SCREW IT WAS VERY SMALL PIECE. IT WAS THE LAST SCREW IN PLATE. THE SURGEON USED THE CHISEL TO TRY TO RETRIEVE THE TIP, WHICH WAS 2MM INSIDE THE PATIENT BONE. IT WAS CONFIRMED THAT THE SCREW WAS FULLY INTACT. THE SURGEON COULD NOT REMOVE THE TIP OF THE SCREWDRIVER OUT OF THE SCREW SO THE PIECE WAS LEFT IT INSIDE PATIENT. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE; THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT¿S STATUS/OUTCOME IS REPORTED AS GOOD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406750 LARGE HEXAGONAL SCREWDRIVER SHAFT SCREWDRIVERS HXX SYNTHES BRANDYWINE 5138119

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR