BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEM GDEFR B/T/B *EA

    MDR report key: 10443073 · Received August 24, 2020

    Report

    Report Number
    1221934-2020-02287
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 6, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705002962
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: CORRECTION: D10: THE DATE DEVICE RETURNED TO MANUFACTURER HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. 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 FADED. THE SCREW WERE NOT ATTACHED IN THE DEVICE. IT SEEMS TO BE BROKEN. 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 ASSEMBLE THE 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: UDI: (B)(4). INCOMPLETE THE LOT NUMBER IS UNKNOWN AT THIS TIME.

    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
    908116 RIGIDFIX FEM GDEFR B/T/B *EA BONENAIL GUIDEWIRE LXH DEPUY MITEK LLC US 213702 UNKNOWN 10886705002962

    Patients

    Seq Age Sex Outcome Treatment
    1