BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM MILLING BIT-STERILE

    MDR report key: 3133139 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01484
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE CORRECT MATERIAL WAS USED AND MET THE HARDNESS AND ALL REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO INCOMING / FINAL INSPECTION. THERE WERE NO COMPLAINT-RELATED ANOMALIES.

    Description of Event or Problem · 1

    SURGEON WAS USING A 2.0MM STERILE MILLING BIT AND FOLLOWING THE TECHNIQUE GUIDE WHEN THERE WAS A SUDDEN BREAKAGE OF THE DEVICE. REPORTEDLY, THE PATIENT HAD HARD BONE. THERE WAS NO PATIENT HARM, NO FRAGMENTS AND THE SURGERY WAS DELAYED 3 MINUTES. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236491 2.0MM MILLING BIT-STERILE BIT GFG SYNTHES MONUMENT 6940352

    Patients

    Seq Age Sex Outcome Treatment
    1