BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC F/K-WIRES Ø0.6-3.2 F/COMPACT AIR DRIV

    MDR report key: 3033570 · Received April 3, 2013

    Report

    Report Number
    2520274-2013-01809
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ACTUAL DEVICE WAS NOT RETURNED, ONLY METAL SHAVINGS. IT IS NOT CLEAR WHICH DEVICE THE SHAVINGS ARE FROM. 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

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: AFTER THE CLEANING WITH ALKALINE DETERGENT A FUNCTION CONTROL WAS PERFORMED DURING WHICH SOME METAL SHAVINGS FELL OUT. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136972 QC F/K-WIRES Ø0.6-3.2 F/COMPACT AIR DRIV HWE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1