BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLYAXL OPN SCRWDRVER MODULAR TI MOD

    MDR report key: 1234062 · Received November 4, 2008

    Report

    Report Number
    1649384-2008-00556
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    August 22, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DID NOT OCCUR IN SURGERY. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. DEVICE MANUFACTURE DATE IS UNK. DEVICE WAS NOT AVAILABLE FOR EXAMINATION. DESIGN HISTORY FILE WAS NOT REVIEWED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE REPORTER INDICATED THE DRIVER TIPS WERE BENT. AN ENGINEERING INVESTIGATION DETERMINED THE MOST LIKELY CAUSE OF BENT TIPS IS DUE TO OFF-AXIS USE OR USE OF THE DRIVER FOR HARDWARE REMOVAL. THE SURGICAL TECHNIQUE WAS ENHANCED IN (B)(6) 2007 TO CAUTION AGAINST OFF AXIS USE AND USE FOR HARDWARE.

    Description of Event or Problem · 1

    ON AUGUST 22, 2008, THE SALES REP REPORTED THAT DURING A KIT INSPECTION, IT WAS NOTICED THAT THE TIPS WERE WORN. ADD'L INFO WAS RECEIVED VIA TELEPHONE ON AUGUST 29, 2008, THE SALES REP REPORTED THAT THE OPEN POLYAXIAL SCREWDRIVERS, PART NUMBER 2153-13 WERE WORN AND THE PRONGS WERE BENT. ON OCTOBER 30, 2008, IT WAS IDENTIFIED AFTER REVIEWING THE DESIGN OF THE TIPS OF THE DRIVER THAT IT IS OF SIMILAR DESIGN TO 2153-7 WHICH HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLYAXL OPN SCRWDRVER MODULAR TI MOD INCOMPASS MNI ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1