BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLIFE LARGE ASPTC HOUSING

    MDR report key: 3781574 · Received April 30, 2014

    Report

    Report Number
    0001811755-2014-01556
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, HOUSING FRACTURED AND DISASSEMBLED, WAS CONFIRMED. THE ENGINEERING TECHNICIAN OBSERVED THAT THE TOP HOUSING WAS SEPARATED OR FRACTURED COMPLETELY OFF OF THE LOWER HOUSING. NO OTHER SYMPTOM FAILURES WERE IDENTIFIED. POTENTIAL CAUSES FOR A CRACKED HOUSING INCLUDE EXCESSIVE AUTOCLAVE EXPOSURE, EXPOSURE TO HIGH PH CLEANERS, CLEANING SOLVENTS, OR IMPACT. DEVICE IS PLACED IN PARTS RETENTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 ASEPTIC HOUSING DISASSEMBLED DURING INSPECTION AT USER FACILITY. IT FRACTURED AND TOP HOUSING WAS DETACHED FROM THE BOTTOM HOUSING. 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 SYSTEM 7 ASEPTIC HOUSING DISASSEMBLED DURING INSPECTION AT USER FACILITY. IT FRACTURED AND TOP HOUSING WAS DETACHED FROM THE BOTTOM HOUSING. 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
    259713 SMARTLIFE LARGE ASPTC HOUSING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 13168

    Patients

    Seq Age Sex Outcome Treatment
    1