BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALL POWERPRO PIN DRIVER

    MDR report key: 533873 · Received June 15, 2004

    Report

    Report Number
    533873
    Event Type
    Other
    Date Received
    June 15, 2004
    Date of Event
    May 24, 2004
    Report Date
    June 9, 2004
    Manufacturer
    LINVATEC CORP
    Product Code
    GFC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE HALL POWERPRO PIN DRIVER TO PLACE A PIN IN A PT'S HIP, THE INNER HOUSING THAT HOLDS THE PIN BROKE APART. WHEN THIS OCCURRED, SHARP METAL SHARDS SHOT OUT THE BACK OF THE WIRE DRIVER/DRILL. THREE OF THE PIECES WHERE RETRIEVED, THE FOURTH WAS NOT. THIS CASE WAS A PERCUTANEOUS CASE WITH VERY SMALL INCISIONS AND BECAUSE THE OTHER 3 PIECES SHOT OUT ON THE FLOOR, IT APPEARS THAT THE MISSING PIECE WAS NOT IN THE PT. FLUOROSCOPY/X-RAY WAS BEING USED TO GUIDE THE PLACEMENT OF THE ORTHOPEDIC HARDWARE AND SHOWED NO EVIDENCE OF FOREIGN BODY IN THE PT. THIS PIN DRIVER WAS BRAND NEW FROM THE CO AND THIS WAS ITS FIRST DAY OF USE. USER FACILITY HAS HAD REPEATED PROBLEMS WITH RELIABILITY OF THIS PRODUCT. THE CO PROFESSES THAT USER FACILITY SEEM TO BE THE ONLY HOSP IN THE AREA THAT IS HAVING THESE PROBLEMS AND HAS REPORTED THAT NO OTHER FACILITIES HAVE REPORTED ISSUES/CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL POWERPRO PIN DRIVER SURGICAL PIN DRIVER GFC LINVATEC CORP PRO3333 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other - CATALOG # PRO5100.| HALLL LINVATEC POWER PRO BATTERY MODULAR HANDPIECE