BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 NON STERILE BATTERY

    MDR report key: 1892521 · Received November 2, 2010

    Report

    Report Number
    1811755-2010-01571
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE UNIT WAS DISASSEMBLED AND FOUND TO HAVE A BROKEN STRAP ON THE POSITIVE TERMINAL, WHICH CREATED ADDITIONAL RESISTANCE AND HEAT. THIS CONDITION WOULD HAVE CREATED THE CRACK IN THE HOUSING. IT WAS ALSO OBSERVED THAT THE NEGATIVE STRAP HAD A BEND THAT IS CONSISTENT WITH AN IMPACT EVENT WHICH COULD ALSO HAVE CAUSED THE BROKEN STRAP ON THE POSITIVE TERMINAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS CRACKED AND LEAKING. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 NON STERILE BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO 09334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK