BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 RECIPROCATING SAW

    MDR report key: 1873686 · Received October 13, 2010

    Report

    Report Number
    1811755-2010-01373
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURE AND A SAMPLE OF THE SUBSTANCE WAS TAKEN FOR FURTHER EVALUATION. RUST THAT APPEARS TO BE MINERAL DEPOSIT BUILD UP ON THE INSIDE OF HANDPIECE WAS FOUND. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CLEANING THE HANDPIECE AFTER A CASE RUSTY WATER BEGAN LEAKING OUT THE BOTTOM. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 RECIPROCATING SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK