BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON T BR ANCHOR W/OC

    MDR report key: 18276714 · Received December 6, 2023

    Report

    Report Number
    1221934-2023-04438
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 6, 2023
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001262
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. D4, H4: THE EXPIRATION DATE AND DEVICE MANUFACTURE DATE WERE REPORTED AS UNKNOWN ON THE INITIAL REPORT; AND HAVE BEEN UPDATED ACCORDINGLY. THEREFORE, UDI: (01)10886705001262(10)116L864(17)251231. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT 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 LOT 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 · 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. 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. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J SALES REPRESENTATIVE. D4, H4: THE DEVICE EXPIRATION DATE AND MANUFACTURE DATE WERE UNKNOWN. UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

    Description of Event or Problem · 0

    T WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGERY ON (B)(6) 2023, THE GRYPHON T BR ANCHOR W/OC ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730449 GRYPHON T BR ANCHOR W/OC FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 116L864 10886705001262

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown