BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON T BR DS ANCH W/OC

    MDR report key: 8920105 · Received August 22, 2019

    Report

    Report Number
    1221934-2019-58087
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    July 25, 2019
    Report Date
    July 26, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001255
    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. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. ONE POSSIBLE ROOT CAUSE FOR THE REPORTED PROBLEM COULD BE THE EXCESSIVE FORCE WAS APPLIED WHILE PULLING THE SUTURE RESULTING IN THE ANCHOR DETACHMENT. HOWEVER WITHOUT THE RETURN OF THE COMPLAINT DEVICE, AND NO FURTHER INFORMATION PROVIDED WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 8/1/2019. 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. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT NON-CONFORMANCE'S WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 8/1/2019. DEVICE HISTORY BATCH, DEVICE HISTORY REVIEW NULL. 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

    PRODUCT COMPLAINT # (B)(4). 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 EMAIL THAT DURING SURGERY THREE GRYPHON T BR DS ANCHOR TRIED TO BE IMPLANTED, WHICH DETACHED AND COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED 3 DEVICES; PRODUCT CODE 210811, OF LOT L630469 WERE USED DURING THE PROCEDURE. IT WAS ALSO REPORTED THERE WAS AN HOUR SURGICAL DELAY WITH NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR; PRODUCT CODE 222245. THE AFFILIATE ALSO REPORTED THE FAILURE OF THE DEVICE OCCURRED WHEN THE SURGEON IMPLANTED THE ANCHOR AND THEN PULL THE SUTURES THE ANCHOR DETACHED. IT WAS STATED THE DEVICES ARE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716780 GRYPHON T BR DS ANCH W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L630469 10886705001255

    Patients

    Seq Age Sex Outcome Treatment
    1