BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT WITH DEPTH

    MDR report key: 2945351 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10033
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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.

    Description of Event or Problem · 1

    DURING AN ORIF PLATING OF 2ND, 3RD, AND 4TH METATARSALS THE FIRST 2.0MM DRILL BIT TIP SNAPPED OFF AND BROKE, A DRILL GUIDE WAS NOT BEING UTILIZED AT THE TIME OF THE BREAKAGE. THE SURGEON STARTED USING THE GUIDE AND AN ADDITIONAL 3 (THREE) 2.0MM DRILL BITS SNAPPED OFF AT THE TIPS. ALL PIECES WERE RETRIEVED, NO PIECES OF THE DRILL BITS ARE IN THE PATIENT'S BONE. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44139 2.0MM DRILL BIT WITH DEPTH HTW SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1