BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 9079484 · Received September 17, 2019

    Report

    Report Number
    1221934-2019-58374
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 19, 2018
    Report Date
    August 20, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. H3, H4, H6 INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED TO DETERMINE IF THE DEVICE HAD ANY GROSS VISUAL DEFECTS THAT MAY CONTRIBUTE TO THE REPORTED FAILURE. THE ANCHOR WAS NOT SENT BACK, ONLY THREE PIECES OF SUTURE RETURNED. THE TWO ORTHOCORD SUTURES ARE FRAYED AND CUT AS REPORTED. THIS COMPLAINT CAN BE CONFIRMED. A POSSIBLE ROOT CAUSE COULD BE THAT THE SUTURE BROKE, WHEN EXCESSIVE TENSION WAS BEING APPLIED ON THE SUTURE OR A SHARP INSTRUMENT CAME IN CONTACT TO THE SUTURE AFTER THE ANCHOR WAS INSERTED. OTHER THAN THOSE POSSIBILITIES, WE CANNOT DISCERN A DEFINITE ROOT CAUSE FOR THIS FAILURE MODE. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 8/21/2019. 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. DEVICE HISTORY: NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 8/21/2019. 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. (B)(4). DEVICE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC SHOULDER JOINT LIP PROCEDURE TREATING SHOULDER JOINT DISLOCATION ON (B)(6) 2019. WHEN THE SURGEON TRIED TO USE THE GRYPHON (210813), IT ALREADY HAD BROKEN SUTURE. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871643 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 210813 2L29511 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1