BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/ORTHOCORD

    MDR report key: 9071601 · Received September 16, 2019

    Report

    Report Number
    1221934-2019-58360
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 19, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS IMPLANTED IN THE PATIENT, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. ONE POSSIBLE ROOT CAUSE FOR THE REPORTED PROBLEM COULD BE OFF-AXIS INSERTION WHICH RESULTED IN THE ANCHOR BREAKING. HOWEVER WITHOUT THE RETURN OF THE COMPLAINT DEVICE, AND NO FURTHER INFORMATION PROVIDED WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 08/19/19. 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. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 08/19/19 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO-CODES: HTY;JDR, MBI. UDI: (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM DEPUY SYNTHES MITEK EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ANCHOR WAS PULLED OUT. IT WAS REPORTED THAT DURING THE OPERATION OF LABRAL FIXATION, WHEN PULL BACK THE SHAFT, NOTED THE ANCHOR WAS ALSO PULLED OUT, AND THE PROXIMAL END OF ANCHOR WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY TIME WAS NOT DELAYED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863196 GRYPHON P BR DS ANCHOR W/ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 210813 3L18791 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1