BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3062488 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-10697
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    December 1, 2011
    Report Date
    December 1, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HSZ. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE REDUCTION PROCEDURE, THE SURGEON WAS USING THE DRILL BIT IN THE DRILL GUIDE AND THE BIT BROKE OFF AT THE POINT WHERE THE BIT FITS INTO THE DRILL COUPLING. IT WAS A CLEAN BREAK AND THERE WERE NO FRAGMENTS TO RETRIEVE FROM THE WOUND. THE SURGEON USED ANOTHER DRILL BIT AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162152 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1