BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 2950889 · Received February 8, 2013

    Report

    Report Number
    1719045-2013-00267
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    November 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODE: HRX. ON THE SPIRAL TUBE BEHIND THE HEAXAGONAL COUPLING, THE FLANK SHOWS SCRATCH MARKS AND SLIGHT PLASTIC DEFORMATION, IT MAY BE ASSUMED THAT THESE WERE CAUSED BY FRAGMENTS FLUSHED AWAY AFTER BREAKAGE OR FROM FRAGMENTS OF OTHER COMPONENTS. A MICRO-METALLOGRAPHIC INSPECTION OF THE RAW MATERIALS REVEALED NO DEVIATIONS ON ANY OF THE FOUR DRILL SHAFTS. THE SHAFT BROKE DUE TO OVERLOAD.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE INSTRUMENT BROKE OFF DURING REAMING. NO FURTHER INFORMATION REPORTED FOR THIS EVENT. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55141 RIA DRIVESHAFT L520 DRIVE SHAFT HTO SYNTHES MONUMENT 15808-01

    Patients

    Seq Age Sex Outcome Treatment
    1