BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/180MM

    MDR report key: 2990265 · Received March 5, 2013

    Report

    Report Number
    3003506883-2013-00086
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. ADDITIONAL PRODUCT CODE - HSZ.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING AN ANKLE SURGERY ON (B)(6) 2013, THE SURGEON WAS DRILLING A HOLE FOR A MEDIAL MALLEOLUS SCREW AND THE 2.5MM DRILL BIT BROKE IN THE PATIENT. THE SURGEON REMOVED A SMALL PIECE OF THE LATERAL CORTEX OF THE TIBIA AND RETRIEVED THE PIECE OF THE DRILL BIT. THE RETRIEVAL OF THE BROKEN PIECE TOOK AN EXTRA 15 MINUTES. ALL THE PIECES OF THE DRILL BIT WERE REMOVED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93076 2.5MM DRILL BIT/QC/GOLD/180MM HTW SYNTHES ELMIRA 7039181

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention