BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 10725971 · Received October 23, 2020

    Report

    Report Number
    1020279-2020-05707
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 2, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE PHOTOS PROVIDED DID NOT CONFIRM THE STATED FAILURE. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORD DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EFIP INSPECTION THE REFLECTION BALL JNT SCREWDRIVER SHAFT WAS FOUND BROKEN. NO INJURIES OR SURGICAL DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194833 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 12DM06932 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1