BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVICE REP DYO PWR LG BATTERY HANDPIECE

    MDR report key: 6892093 · Received September 25, 2017

    Report

    Report Number
    3003604053-2017-00092
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    September 21, 2017
    Report Date
    December 5, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWE
    UDI-DI
    00885554038002
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY THE SUPPLIER AND COULD NOT CONFIRM THE CUSTOMER COMPLAINT FOR THE DEVICE STOPPED WORKING DURING THE ACL PROCEDURE. FUNCTIONAL TESTING WAS PERFORMED AND THE INSTRUMENT PASSED ALL TESTING. THIS DEVICE IS CONSIDERED A NO PROBLEM FOUND. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE STOPPED WORKING DURING THE ACL PROCEDURE. THERE WAS A DELAY OF LESS THAN THIRTY MINUTES. THE PROCEDURE WAS COMPLETED WITH A NON-SMITH & NEPHEW DEVICE. NO INJURIES OR COMPLICATIONS WERE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671134 SERVICE REP DYO PWR LG BATTERY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SMITH & NEPHEW, INC. 00885554038002

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR