BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE SAG SAW

    MDR report key: 1873610 · Received September 17, 2010

    Report

    Report Number
    1811755-2010-01203
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. A CONDITION OF THE DEVICE OVERHEATING WAS FOUND WHEN THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE SAGHEAD ASSEMBLY AND MOTOR CARTRIDGE, WHICH WILL BE REPLACED. SERVICE WILL DO A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT WILL BE REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPURATURE RISE. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES WHEN THIS EVENT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK