BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 LONG F/MATRIX

    MDR report key: 2903511 · Received January 9, 2013

    Report

    Report Number
    1719045-2013-00073
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE PRESENT SCREWDRIVER SHAFT WAS ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. SUBJECT PRODUCT PASSED ALL INSPECTION AND CERTIFICATION TESTING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE IS NOT DISTRIBUTED IN THE US, BUT IT IS SIMILAR TO DEVICE MARKETED IN THE US.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: TIPS OF SCREW DRIVERS WERE DAMAGED DURING LOOSENING OF THE LOCKING CAP. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10959 SCRDRIVERSHAFT T25 LONG F/MATRIX SCRDRIVERSHAFT T25 LONG F/MATRIX HXX SYNTHES MONUMENT 6457221

    Patients

    Seq Age Sex Outcome Treatment
    1