BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R3 STRAIGHT SHELL IMPACTOR

    MDR report key: 10844584 · Received November 16, 2020

    Report

    Report Number
    1020279-2020-06485
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    September 8, 2020
    Report Date
    January 6, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010443236
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6 (HEALTH EFFECT - IMPACT CODE AND COMPONENT CODE) RESULTS OF INVESTIGATION: THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE WELD ON THE BOTTOM OF THE X-BAR CLAMP IS FRACTURED, RENDERING THE DEVICE INOPERABLE. THE DEVICE WAS MANUFACTURED IN 2015 AND SHOWS SIGNS OF EXTENSIVE USE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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. INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE R3 STRAIGHT SHELL IMPACTOR, THE WELD ON THE BOTTOM OF THE X-BAR CLAMP WAS FOUND FRACTURED. NO PROCEDURE-RELATED. THEREFORE, NO INJURIES OR SURGICAL DELAYS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE REFLECTION CUP POSITIONER/IMPACTOR, THE WELD ON THE BOTTOM OF THE X-BAR CLAMP WAS FOUND FRACTURED. NO PROCEDURE-RELATED. THEREFORE, NO INJURIES OR SURGICAL DELAYS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313849 R3 STRAIGHT SHELL IMPACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 71362299 15KSA0022 03596010443236

    Patients

    Seq Age Sex Outcome Treatment
    1