BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASMBLY,RATCHET HANDLE,QUICK DISCONNECT

    MDR report key: 10702128 · Received October 19, 2020

    Report

    Report Number
    1221934-2020-03070
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    January 30, 2020
    Report Date
    October 1, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705020256
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. INVESTIGATION SUMMARY THE COMPLAINT DEVICE LOT NUMBER 1110001, WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEAL THAT THE DEVICE IS DULL, AND THE DEVICE APPEARS WORN. FUNCTIONAL TESTING WAS MADE AT THE QUICK DISCONNECT COMPONENT, AND IT WAS CONFIRMED THAT THE RATCHET PRESENTED NOT FULLY TENSION OR TIGHTEN. WHEN THE DRIVER WAS OPERATED IN FORWARD AND REVERSE DIRECTIONS MAKES CONSTANT NOISES, IN ADDITION, IT DOES NOT RATCHET BUT ROTATES FREELY INDICATING IT IS STRIPPED INTERNALLY. THE COMPLAINT CAN BE CONFIRMED. LOT NUMBER ON THE DEVICE INDICATES THIS DEVICE IS 9 YEARS OLD AND HENCE THIS FAILURE CAN BE ATTRIBUTED TO NORMAL FIELD WEAR. HOWEVER, THIS CANNOT BE CONCLUSIVE. AS A POTENTIAL CAUSE CANNOT BE ASSOCIATED TO MANUFACTURING, THEREFORE A MANUFACTURING RECORD EVALUATION IS NOT REQUIRED. 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 · 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. D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. UDI:(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: HAD AN ACL USING MILAGRO SCREWS. WE ATTACHED THE MILAGRO DRIVER TO THE BLACK QUICK CONNECT HANDLE REF: 219970 LOT: 1110001. AFTER SCREWING IN THE SCREW THE RATCHET HANDLE KEPT ON FALLING OFF. WE WERE HAVING A DIFFICULT TIME CONNECTING THE RATCHET HANDLE TO THE DRIVER AND TAKING OUT THE DRIVER. THE BLACK HANDLE CONTINUED TO DISCONNECT FROM DRIVER WHEN WE MALLETING THE CONNECTION PART. WE EVENTUALLY REMOVED THE DRIVER AND TRIED ANOTHER RATCHET HANDLE REF: 219970 LOT: 1303001 AND THE RATCHET HANDLE CONTINUES TO SLIP OFF IF YOU MALLET TOWARDS THE CONNECTOR. NO SURGERY DELAY. NO PATIENT CONSEQUENCES. THE DEVICES ARE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162836 ASMBLY,RATCHET HANDLE,QUICK DISCONNECT SURGICAL SCREWDRIVER, REUSABLE LXH DEPUY MITEK LLC US 219970 1110001 10886705020256

    Patients

    Seq Age Sex Outcome Treatment
    1