BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR TPS MICRO DRILL

    MDR report key: 1637468 · Received March 9, 2010

    Report

    Report Number
    1811755-2010-00220
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 11, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVAL, BUT BASED ON THE QA INVESTIGATION DETAILS THE REPORTED CONDITION OF THE DEVICE OVERHEATING DURING USAGE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING AN ORTHOPAEDIC FOOT PROCEDURE. THERE WAS NO REPORTED PT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR TPS MICRO DRILL SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK