BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRIFXQA+ W/#4OC C1

    MDR report key: 10814379 · Received November 9, 2020

    Report

    Report Number
    1221934-2020-03394
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    January 1, 2020
    Report Date
    October 24, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001903
    PMA / PMN Number
    K150209
    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 ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING EXTENSOR TENDON REPAIR, THE SHAFT ATTACHING THE ANCHOR TO THE INSERTER BROKE OFF. THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [L982494] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: DURING EXTENSOR TENDON REPAIR, AS THE DOCTOR WENT TO INSERT THE ANCHOR THE SHAFT ATTACHING THE ANCHOR TO THE INSERTER BROKE OFF. THE SURGERY WAS COMPLETED WITH ANOTHER ANCHOR. THE DEVICE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED FRAGMENTS WERE GENERATED BUT ALL PIECES WERE RECOVERED. THERE WAS A 5 MINUTE SURGICAL DELAY BUT NO COMPLICATION TO THE PATIENT WAS REPORTED. IT WAS ALSO STATED THAT THE DEVICE WAS DISCARDED BY THE FACILITY AND CANNOT BE RETURNED FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272280 MICRIFXQA+ W/#4OC C1 SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 212045 L982494 10886705001903

    Patients

    Seq Age Sex Outcome Treatment
    1