BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLIFE LARGE ASPTC HOUSING

    MDR report key: 3853049 · Received June 6, 2014

    Report

    Report Number
    0001811755-2014-02076
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED BY THE QA TECHNICIAN THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY AND VISUAL INSPECTION. THE TECHNICIAN DETERMINED THROUGH VISUAL INSPECTION THAT THE HOUSING WAS CRACKED NEAR THE HINGE. IT IS POSSIBLE BASED ON THE RISK DOCUMENT THAT THE DAMAGE WAS CAUSED BY EXCESSIVE SIDELOAD. THE HOUSING WAS PLACED IN PARTS RETENTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LID OF THE HOUSING IS BROKEN DURING INSPECTION AT USER FACILITY DURING INSPECTION. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LID OF THE HOUSING IS BROKEN DURING INSPECTION AT USER FACILITY DURING INSPECTION. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332842 SMARTLIFE LARGE ASPTC HOUSING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 13247

    Patients

    Seq Age Sex Outcome Treatment
    1