BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLIFE LARGE ASPTC HOUSING

    MDR report key: 4230881 · Received November 6, 2014

    Report

    Report Number
    0001811755-2014-03972
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1811755-09/17/14-001-R
    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 DISASSEMBLED AS IT FRACTURED/DETACHED FROM THE TOP HOUSING, WAS CONFIRMED. NO OTHER SYMPTOM FAILURES WERE FOUND. AN ASEPTIC HOUSING TOP DAMAGED-CRACKED WAS DETERMINED. DEVICE WAS 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 AFTER STERILIZATION PROCEDURE AT USER FACILITY THAT THE ASEPTIC HOUSING FRACTURED AND TOP HOUSING WAS DETACHED FROM THE LOWER 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 AFTER STERILIZATION PROCEDURE AT USER FACILITY, THE ASEPTIC HOUSING FRACTURED AND TOP HOUSING WAS DETACHED FROM THE LOWER 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
    713654 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