BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST FX STRUT FOR TSF MED

    MDR report key: 12874512 · Received November 25, 2021

    Report

    Report Number
    1020279-2021-08389
    Event Type
    Malfunction
    Date Received
    November 25, 2021
    Date of Event
    January 1, 1901
    Report Date
    February 1, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    UDI-DI
    03596010443892
    PMA / PMN Number
    K994143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTION TO THE EVENT DESCRIPTION.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE'S THREAD COMPONENTS WERE DAMAGED WHICH PREVENTED THE DEVICE FROM TIGHTENING AGAIN. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE, BUT NO SIMILAR EVENTS FOR THE BATCH, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS 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. THE MANUFACTURING PROCESS OF THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. SOME POTENTIAL PROBABLE CAUSES COULD BE BUT ARE NOT LIMITED TO USER ERROR OR EXCESSIVE LOADING ON 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. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE SHOULDER BOLTS OF A FAST FX STRUT FOR TSF MED AND FAST FX STRUT FOR TSF SHT WERE TIGHTENED BY HAND AND COULD THEN ONLY BE RELEASED WITH A WRENCH. BOTH THREADS WERE BROKEN AS A RESULT. THE SHOULDER BOLT ON THE FAST FX STRUT FOR TSF MED EVEN BROKE OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION, THE SHOULDER BOLTS OF A FAST FX STRUT FOR TSF MED AND FAST FX STRUT FOR TSF SHT WERE TIGHTENED BY HAND AND COULD THEN ONLY BE RELEASED WITH A WRENCH. BOTH THREADS WERE BROKEN AS A RESULT. THE SHOULDER BOLT ON THE FAST FX STRUT FOR TSF MED EVEN BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771048 FAST FX STRUT FOR TSF MED PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC. 71070720 19LSM0183 03596010443892

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 71070710, FAST FX STRUT, LOT: 19LSM0196.