BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES DRILL

    MDR report key: 2891077 · Received November 14, 2012

    Report

    Report Number
    1811755-2012-04077
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF THE DEVICE PRODUCING METAL SHAVINGS WAS NOT DUPLICATED. HOWEVER, SCORING DAMAGE WAS FOUND ON THE DRIVESHAFT, WHICH WAS IDENTIFIED AS A PROBABLE CAUSE OF THE REPORTED METAL SHAVINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL PRODUCED METAL SHAVINGS IN THE STERILE FIELD, WHEN USED WITH THE CORDLESS DRIVER. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED PRIOR TO THE SURGICAL PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES DRILL HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATALOG # 4200000000, SERIAL # (B)(4)| CORDLESS DRIVER 2