BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R3 STRAIGHT SHELL IMPACTOR

    MDR report key: 12697862 · Received October 26, 2021

    Report

    Report Number
    1020279-2021-07666
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 29, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010607034
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G3, H2, H3, AND H6: THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED R3 STRAIGHT SHELL IMPACTOR CONFIRMS THE WELD ON THE SHAFT OF IMPACTOR HANDLE IS BROKEN. THIS DEVICE ALSO SHOWS EXCESSIVE WEAR AND TEAR RENDERING THE DEVICE INOPERATIVE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY 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 AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED. G4: ADD 510K CODE

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THR SURGERY, THE WELD ON THE SHAFT OF IMPACTOR HANDLE OF A R3 STRAIGHT SHELL IMPACTOR WAS BROKEN. SURGERY WAS FINISHED WITH A S&N BACKUP DEVICE, WITH LESS THAN 30 MINUTES OF SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595516 R3 STRAIGHT SHELL IMPACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 71364450 19ESA0001 03596010607034

    Patients

    Seq Age Sex Outcome Treatment
    1