BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEMROD 10MM *EA

    MDR report key: 10536759 · Received September 15, 2020

    Report

    Report Number
    1221934-2020-02627
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 31, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FZX
    UDI-DI
    10886705003044
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT AFTER AN ACL PROCEDURE THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK AND THE RIGIDFIX FEMORAL ROD 10 MM 1PK GOT STUCK TOGETHER. IT LOOKS LIKE THE SCREW BROKE UP AND GOT STUCK IN THE GUIDE. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEALED THAT THE DEVICE WAS WORN. ALSO, IT WAS FOUND WITH SCRATCHES, AND THE LASER MARKS WAS SLIGHTLY FADED. THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK ,AND THE RIGIDFIX FEMORAL ROD 10 MM 1PK G FROM THE SHAFT CONNECTION POINT REVEALED THAT THE DEVICE HAD BEEN HEAVILY USED DUE TO THE METAL SURFACE HAD STRIATIONS, AND IT APPEARED TO LOSE THE METAL. IT WAS DIFFICULT TO ASSEMBLED THE BOTH DEVICES. AS A RESULT, IT WAS JAMMED. THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROUTE CAUSE COULD BE RELATED TO THE USE AND SERVICING, THIS FAILURE CAN BE ATTRIBUTED TO THE FIELD WEAR. FOR THE DAMAGE IN THE METAL CAN BE ATTRIBUTE WHEN THE DEVICE MIGHT HAVE BEEN TAPPED AGAINST A HARD SURFACE ON SEVERAL OCCASIONS AND WILL GENERATE WEAR IN THE METAL. THEREFORE, IT CAN GENERATE DIFFICULT TO ASSEMBLE BECAUSE OF THE DAMAGE OBSERVED. HOWEVER, IT CANNOT BE CONCLUSIVELY AFFIRMED. GIVEN THAT NO LOT NUMBER WAS PROVIDED, A MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE PERFORMED. IF THE LOT NUMBER BECOMES AVAILABLE, THE MRE REVIEW WILL BE PERFORMED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4). THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT AFTER AN ACL PROCEDURE THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK AND THE RIGIDFIX FEMORAL ROD 10 MM 1PK GOT STUCK TOGETHER. IT LOOKS LIKE THE SCREW BROKE UP, AND GOT STUCK IN THE GUIDE. NO PATIENT CONSEQUENCES OR PROCEDURE DELAY REPORTED AS THE CASE WAS ALREADY COMPLETED. THESE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002202 RIGIDFIX FEMROD 10MM *EA BONENAIL GUIDEWIRE FZX DEPUY MITEK LLC US 213710 UNKNOWN 10886705003044

    Patients

    Seq Age Sex Outcome Treatment
    1