BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTERY REAMER/DRILL II

    MDR report key: 3817574 · Received May 19, 2014

    Report

    Report Number
    3009450871-2014-10148
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    September 9, 2013
    Report Date
    September 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS PART OF A MARKET PREFERENCE EVALUATION FOR BPL II. DURING A TOTAL HIP REPLACEMENT, THE REAMER WAS IN INADVERTENT REVERSE ENGAGEMENT WHEN PASSED BACK AND FORTH. THE PATIENT'S BONE QUALITY IS DENSE/NORMAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296881 BATTERY REAMER/DRILL II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR