BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R3 OFFSET IMPACTOR TIP

    MDR report key: 10631696 · Received October 5, 2020

    Report

    Report Number
    1020279-2020-05162
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 10, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    UDI-DI
    03596010599391
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION OF THE RETURNED IMPACTOR TIP CONFIRMS THE DEVICE FRACTURED INTO TWO PIECES. ONLY ONE PIECE WAS RETURNED FOR EVALUATION. THIS DEVICE EXHIBITS SIGNS OF SIGNIFICANT USE AND WEAR. THERE IS NO LOT NUMBER PROVIDED FOR THIS DEVICE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. THE DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES AND CLEANING CYCLES. AS PLASTICS ARE VULNERABLE AND CRACK MAY HAVE INITIATED DURING USE AND POSSIBLE CAUSES COULD BE DUE TO THE HEATING AND COOLING ASSOCIATED WITH AUTOCLAVING OR PROLONGED USE. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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 WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING E FIP INSPECTION THE R3 OFFSET IMPACTOR TIP BROKE IN HALF. NO CASE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092109 R3 OFFSET IMPACTOR TIP PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEME, MET/POLY HRY SMITH & NEPHEW, INC. 71363077 UNKNOWN 03596010599391

    Patients

    Seq Age Sex Outcome Treatment
    1