BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST FX STRUT FOR TSF SHT

    MDR report key: 11781314 · Received May 5, 2021

    Report

    Report Number
    1020279-2021-03771
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 12, 2021
    Report Date
    October 14, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    UDI-DI
    03596010474308
    PMA / PMN Number
    K994143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT CONFIRM THE STATED FAILURE MODE. THE DEVICE SHOWS SIGNS OF EXTENSIVE USE. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. 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. WEAR POTENTIAL CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO FRICTION, JOINT TIGHTNESS OR LIFETIME OF DEVICE. 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 FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (3) FAST FX STRUT FOR TSF {} MED (CASE (B)(4), CASE (B)(4), CASE (B)(4)), (6) FAST FX STRUT X-SHORT (CASE (B)(4), CASE (B)(4), CASE (B)(4), CASE (B)(4), CASE (B)(4), CASE (B)(4)), (6) FAST FX STRUT FOR TSF {} SHT (CASE (B)(4), CASE (B)(4), CASE (B)(4), CASE (B)(4), CASE (B)(4), CASE (B)(4)) AND (1) FAST FX STRUT FOR TSF {} LNG (CASE (B)(4)) ARE LOOSING THE BLACK COATING ON THE OUTSIDE MAKING IMPOSSIBLE TO READ THE NUMBERS. SOME ALSO WILL NOT ALLOW THE SHOULDER BOLTS TO THREAD IN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674769 FAST FX STRUT FOR TSF SHT PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC. 71070710 19DSM0540 03596010474308

    Patients

    Seq Age Sex Outcome Treatment
    1