BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB

    MDR report key: 3062285 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-10910
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 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

    IT WAS REPORTED THAT A DRILL BIT BROKE DURING AN ORIF (OPEN REDUCTION INTERNAL FIXATION) PROCEDURE. THE SURGEON HIT THE DRILL BIT AGAINST THE EXISTING SCREW WHEN DRILLING. ALL PIECES WERE RETRIEVED. THE SURGEON USED ANOTHER DRILL BIT AND COMPLETED THE PROCEDURE. NO HARM TO THE PATIENT AND NO TIME DELAY FOR THE PROCEDURE WAS REPORTED. EVENT #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162281 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1