BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 1913842 · Received November 26, 2010

    Report

    Report Number
    1811755-2010-01811
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE TURNING ON BY ITSELF IN SAFE MODE WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE DRIVESHAFT, BEARINGS, TRIGGER SHAFT, AND OTHER PARTS RELATED TO A 3RD PARTY REPAIR. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER TURNED ON BY ITSELF IN SAFE MODE WHILE THE EQUIPMENT WAS BEING TESTED. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK