BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 6 STERILIZATION CASE

    MDR report key: 3830636 · Received May 23, 2014

    Report

    Report Number
    0001811755-2014-01904
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PAINT FLAKING WAS CONFIRMED BY A MANUFACTURER FIELD REPAIR TECHNICIAN THROUGH VISUAL INSPECTION. THE CAUSE OF THIS IS THE POWDERCOAT MATERIAL IS NOT DURABLE ENOUGH TO SURVIVE THROUGH AUTOCLAVES, WASHES, AND ROUGH HANDLING. THE DEVICE WAS ARCHIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PAINT ON THE HANDPIECE INSERT OF THE SYSTEM 6 STERILIZATION CASE WAS FLAKING OFF DURING TESTING OR SET UP PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PAINT ON THE HANDPIECE INSERT OF THE SYSTEM 6 STERILIZATION CASE WAS FLAKING OFF DURING TESTING OR SET UP PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308424 SYS 6 STERILIZATION CASE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1