BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION WRENCH Ø11

    MDR report key: 3242471 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04409
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXC
    PMA / PMN Number
    PREAMENDMENT
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THE REVIEW OF THE RING SPANNER HAS SHOWN THAT THE VISIBLE MARKS ON THE SURFACE CONSIST ONLY PARTLY OF RUST. THE TRACES CAN BE REMOVED MECHANICALLY. THESE TRACKS CAN OCCUR IF THE KEY IS NOT CLEANED PROPERLY OR IF IT HAS NOT DRIED AFTER CLEANING ACCORDINGLY (FROM RESIDUAL MOISTURE IN RUST). THIS HAS THE CONSEQUENCE THAT RUST IS FORMED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, THE WRENCH WAS OBSERVED WITH CORROSION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342811 COMBINATION WRENCH Ø11 HXC SYNTHES GMBH 7585817

    Patients

    Seq Age Sex Outcome Treatment
    1