BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE G-W NTNL 1.1MMX15 6PK

    MDR report key: 9330829 · Received November 15, 2019

    Report

    Report Number
    1221934-2019-59553
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 22, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FZX
    UDI-DI
    10886705013050
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [4L95736] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SINCE THE COMPLAINT DEVICE WAS DISCARDED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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 EXPIRATION DATE IS UNKNOWN

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ACL CASE THE PINS OF THE ABSOLUTE G-W NTNL 1.1MMX15 6PK BROKE, THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND THE SURGEON HAD TO REMOVE THE MILAGRO ADVANCE SCREW 11X30MM AND THE CORTICAL FXATION FXD LOOP 15MM FROM FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND LOOKED FOR THE WIRE TIP, THE GUIDE WIRE TIP WAS FOUND AND WAS REMOVED FROM THE PATIENT, BUT THE SCREW WAS A LITTLE DEFORMED. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICES. NO PATIENT CONSEQUENCE WAS REPORTED. HOWEVER, THERE WAS A SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED A 30 MINUTE SURGICAL DELAY. THE AFFILIATE ALSO REPORTED ONLY ONE FRAGMENT WAS GENERATED AND IT WAS SUCCESSFULLY REMOVED BY THE SURGEON. IT WAS ALSO REPORTED THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND SURGEONS NEED TO REMOVE THE 231824 AND 15MM RIGIDLOOP 232009 X1 (LOT 4L23984) AT FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND SEARCH FOR THE GUIDE WIRE TIP. THE AFFILIATE REPORTED THAT NORMAL FORCE WAS APPLIED TO REMOVE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122545 ABSOLUTE G-W NTNL 1.1MMX15 6PK BONENAIL GUIDEWIRE FZX DEPUY MITEK LLC US 4L95736 10886705013050

    Patients

    Seq Age Sex Outcome Treatment
    1