BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SMARTLIFE SMALL ASPTC HOUSING

    MDR report key: 5830803 · Received July 28, 2016

    Report

    Report Number
    0001811755-2016-01444
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 2, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM, EXEMPTION NUMBER E2015055. (B)(6) DEVICES WERE RECEIVED FOR EVALUATION; 1 EVENT WAS CONFIRMED DURING TESTING. (B)(6) DEVICE WAS FOUND TO BE AFFECTED BY O-RING DEGRADATION. THE REPORTED EVENT WAS NOT CONFIRMED FOR (B)(6) DEVICE; THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS FOR THE REPORTED EVENT. THIS DEVICE IS NOT REPAIRABLE AND WAS NOT RETURNED TO THE USER FACILITY. THERE WERE NO REMEDIAL ACTIONS TAKEN.  THIS DEVICE IS NOT LABELED FOR SINGLE-USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A CONDITION IN WHICH THE NON-STERILE BATTERY HAD THE POTENTIAL TO BE EXPOSED TO THE SURGICAL SITE. TWO REPORTED EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483795 SMARTLIFE SMALL ASPTC HOUSING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1