BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT/QC/125MM

    MDR report key: 3912170 · Received July 3, 2014

    Report

    Report Number
    2520274-2014-12361
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    PK962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE A DUPLICATE OF (B)(4). INFORMATION WAS ALREADY REPORTED ON MEDWATCH MW-119075; MFR NUMBER 2520274-2014-12358. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. 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 AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT TIBIAL FRACTURE, THE TIP OF THE DRILL BIT BROKE OFF APPROXIMATELY 1MM FROM THE TIP AT THE EDGE OF THE BONE. THE SURGEON WAS ABLE TO SUCTION THE BROKEN DRILL BIT FROM THE BONE. ANOTHER DRILL BIT FROM THE SET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN SURGERY AND THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH IMPLANTATION OF A PLATE AND SCREW CONSTRUCT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390338 2.0MM DRILL BIT/QC/125MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESSORIES & ATTACHMENTS HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1