BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM

    MDR report key: 2940889 · Received February 4, 2013

    Report

    Report Number
    1719045-2013-00208
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. IT WAS REPORTED ON (B)(6) 2013 THAT THE SCREW DRIVER WAS THROWN AWAY BY THE PROCESSING STAFF AT THE COMPLAINING FACILITY AND WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A STARDRIVE SCREWDRIVER WAS FOUND WITH A BROKEN SHAFT IN THE TRAY DURING RESTOCKING. THIS WAS DISCOVERED IN AN INSTRUMENT ROOM AFTER A PROCEDURE. IT IS UNKNOWN WHEN OR HOW THE INSTRUMENT BROKE. THERE WAS NO REPORTED PATIENT CONTACT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46540 STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM STARDRIVE SCREWDRIVER HXX SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1