BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.76MM DRILL BIT/STRYKER J-LATCH/10MM STOP/44.5MM

    MDR report key: 2883052 · Received December 21, 2012

    Report

    Report Number
    2520274-2012-04257
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING SURGERY ON (B)(6) 2012, A MOD HAND 0.76MM DRILL BIT BROKE OFF INTO THE PATIENT. THE SURGEON FELT IT WOULD BE MORE HARMFUL TO REMOVE THE FRAGMENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.76MM DRILL BIT/STRYKER J-LATCH/10MM STOP/44.5MM DRILL BIT HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1