BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM CANNULATED DRILL BIT LARGE QC/300MM

    MDR report key: 2932778 · Received January 29, 2013

    Report

    Report Number
    1719045-2013-00206
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. USER FACILITY REPORTED THE COMMON DEVICE NAME AS SCREW, FIXATION, BONE; COMMON DEVICE NAME CORRECTED TO CANNULATED DRILL BIT. MANUFACTURER NAME, CITY AND STATE CORRECTED FROM SYNTHES USA, (B)(4) TO SYNTHES (B)(4). OTHER #: USER FACILITY REPORTED OTHER # AS 310.63; 310.63 IS THE CATALOG/PART # AND CORRECTION WAS MADE.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38684 5.0MM CANNULATED DRILL BIT LARGE QC/300MM CANNULATED DRILL BIT HTW SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1