BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

    MDR report key: 2982013 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-00419
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE PROVIDED HTW. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED, THERE WERE THREE DHRS REVIEWED FOR LOT NUMBER U166498. ALL THREE DHRS INDICATED THE CORRECT MATERIAL WAS USED AND THE CORRECT HARDNESS VALUES WERE OBTAINED. ALL THREE LOTS WERE INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES, FOR EACH OF THESE DHRS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING EVALUATION WAS CONDUCTED, DUE TO AN UNKNOWN CAUSE, THE DRILL BIT BROKE NEAR THE QUICK COUPLING END AND THE FLUTES EXHIBIT NICKED AND CHIPPED CUTTING SURFACES. DUE TO THE UNKNOWN CAUSE AND THE EVALUATION PERFORMED, NO CONCLUSION CAN BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING AN ORIF DISTAL RADIUS FRACTURE PROCEDURE, THE DRILL BIT WAS LOADED USING A VARIABLE ANGLE GUIDE, THE DRILL BIT BROKE INTO TWO PIECES AT THE COUPLING WHERE IT CONNECTS TO THE SHAFT. THERE WERE NO FRAGMENTS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88632 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM HTW SYNTHES MONUMENT U166498

    Patients

    Seq Age Sex Outcome Treatment
    1