BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION

    MDR report key: 4130213 · Received September 30, 2014

    Report

    Report Number
    1719045-2014-10482
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES HERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THERE IS NO DRAWING ON FILE FOR THIS PART. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PROCEDURE TO TREAT A PELVIC WALL ACETABULUM FRACTURE SUFFERED IN A HEAD ON MOTOR VEHICLE COLLISION, A DRILL BIT BROKE AT THE TIP, WHILE DRILLING FOR A SCREW. ABOUT ONE INCH OF THE TIP IS REPORTED TO BE EMBEDDED IN THE BONE AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM OR SURGICAL DELAY WAS REPORTED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608448 2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION BIT, DRILL HTW SYNTHES MONUMENT UR79065

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR