BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R3 STRAIGHT SHELL IMPACTOR

    MDR report key: 10935228 · Received December 2, 2020

    Report

    Report Number
    1020279-2020-06913
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 2, 2020
    Report Date
    March 18, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010607034
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: IT WAS REPORTED THAT AFTER THR PROCEDURE THE WELD ON THE HANDLE OF R3 STRAIGHT SHELL IMPACTOR WAS FOUND TO BE BROKEN. NO DELAY OR BACK UP APPLICABLE FOR THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. THE AFFECTED COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE A PRODUCT ANALYSIS COULD NOT BE PERFORMED. OUR INVESTIGATION INCLUDING A REVIEW OF THE MANUFACTURING RECORDS FOR THE LISTED BATCH DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. THERE IS NO INFORMATION THAT WOULD SUGGEST THE DEVICE FAILED TO MEET SPECIFICATIONS. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE IMPACTOR WAS MANUFACTURED IN 2017 AND THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. 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. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. WE WILL CONTINUE TO TREND THROUGH OUR POST MARKET SURVEILLANCE PROCESS. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THR PROCEDURE THE WELD ON THE HANDLE OF R3 STRAIGHT SHELL IMPACTOR WAS FOUND TO BE BROKEN. NO DELAY OR BACK UP APPLICABLE FOR THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399909 R3 STRAIGHT SHELL IMPACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 71364450 17HSA0006 03596010607034

    Patients

    Seq Age Sex Outcome Treatment
    1