BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLIFE LARGE ASPTC HOUSING

    MDR report key: 3760715 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01382
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION. DEVICE IS NOT RETURNED TO THE MANUFACTURER FACILITY FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION, SO THE REPORTED EVENT COULD NOT BE CONFIRMED IN THIS CASE. BASED ON A REVIEW OF RISK DOCUMENTATION AND COMPLAINTS WITH A SIMILAR REPORTED EVENT, A POSSIBLE CAUSE MOST OFTEN IDENTIFIED IN RELATION TO THIS COMPLAINT IS A WORN/DAMAGED RUBBER O-RING FAILURE. AN O-RING FAILURE CAN RESULT IN DOOR SEAL INTEGRITY BEING COMPROMISED WITH THE POSSIBILITY FOR STERILITY RELATED REVERSIBLE INJURIES. HOWEVER, THAT WAS NOT ABLE TO BE CONFIRMED IN THIS CASE SINCE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE O-RING ON LID OF THEIR BATTERY HOUSING WAS BROKEN DURING INSPECTION AT THE USER FACILITY. 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 O-RING ON LID OF THEIR BATTERY HOUSING WAS BROKEN DURING INSPECTION AT THE USER FACILITY. 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
    239336 SMARTLIFE LARGE ASPTC HOUSING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 13169

    Patients

    Seq Age Sex Outcome Treatment
    1