BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET MENISCUS MENDER II DISPOSABLE

    MDR report key: 10760294 · Received October 30, 2020

    Report

    Report Number
    1219602-2020-01715
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    September 25, 2020
    Report Date
    December 18, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HQW
    UDI-DI
    03596010468482
    PMA / PMN Number
    K885311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H2: ADDITIONAL INFORMATION: HEALTH EFFECT - CLINICAL AND IMPACT CODE H3, H6: THE REPORTED DEVICE WAS RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A REVIEW OF THE DEVICE DRAWINGS FOUND A STRESS RELIEF COLLAR IS NOW ATTACHED AT THE CONNECTION BETWEEN THE SHAFT AND THE HUB OF THE SUTURE CAPTURE LOOP. THIS DESIGN CHANGE WAS IMPLEMENTED AS A RESULT OF A CORRECTIVE ACTION INITIATED TO ADDRESS THE REPORTED ISSUE. A VISUAL INSPECTION REVEALED THAT BOTH MENISCAL SUTURE LOOPS WERE DETACHED FROM THEIR HANDLES. THIS MOST OFTEN OCCURS WHEN THE DEVICES ARE REMOVED FROM THE PACKAGING BY THE TIPS INSTEAD OF PUSHING BEHIND THE PACKAGING TO RELEASE THE HANDLES. THERE WAS MINIMAL DEBRIS, AND THE REST OF THE SET WAS IN GOOD CONDITION. A REVIEW OF THE CUSTOMER PROVIDED IMAGE FINDS THE COMPLAINT DEVICE WITH THE SUTURE RETRIEVERS FRACTURED FROM THE HUBS AT THE WELD. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH DEVICE DESIGN. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. A CORRECTIVE ACTION FOR THIS FAILURE MODE IS IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, WHEN THE PACKAGE OF THE MENISCUS SET MENDER WAS OPENED, THE HANDLE LASSO BROKE AUTOMATICALLY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231709 SET MENISCUS MENDER II DISPOSABLE CLIP, TANTALUM, OPHTHALMIC HQW SMITH & NEPHEW, INC. 7209485 2034277 03596010468482

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female