BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LID FOR OUTER CASES

    MDR report key: 11646829 · Received April 11, 2021

    Report

    Report Number
    1020279-2021-02833
    Event Type
    Injury
    Date Received
    April 11, 2021
    Date of Event
    March 16, 2021
    Report Date
    October 13, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FSM
    UDI-DI
    03596010415103
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, INTENDED FOR USE, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE HANDLES ON THE DEVICE ARE CRACKED, RENDERING THE DEVICE INOPERABLE. THE DEVICE 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. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11 MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544192 LID FOR OUTER CASES TRAY, SURGICAL, INSTRUMENT FSM SMITH & NEPHEW, INC. 71129402 471440 03596010415103

    Patients

    Seq Age Sex Outcome Treatment
    1