BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 9668139 · Received February 4, 2020

    Report

    Report Number
    1221934-2020-00484
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 29, 2020
    Report Date
    January 29, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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: G1: THE MANUFACTURING SITE NAME WAS REPORTED AS DEPUY SYNTHES ON THE INITIAL REPORT AND HAS BEEN UPDATED TO MEDOS INTERNATIONAL SARL TO REFLECT THE CORRECT INFORMATION. ADDITIONAL INFORMATION: D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. 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: ADDITIONAL INFORMATION: INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE SUTURES WERE KNOTTED. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS CONFIRM THAT ARE MISSING COMPONENTS AS THE 3.0MM ANCHOR, 3.0MM GRYPHON PUSH INSERTER, HANDLE DRIVER PUSH INSERTER, SUTURE, SUTURE CARD, SUTURE GRIPPER, DOUBLE BARREL, COVER, HANDLE, NOT CONFIRMING THIS COMPLAINT. HE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO LOW TENSION APPLIED ON THE SUTURE IN CONJUNCTION WITH CORTICAL THREAD, HOWEVER THIS CANNOT BE CONCLUSIVE DETERMINED. AS A POTENTIAL CAUSE CANNOT BE ASSOCIATED TO MANUFACTURING, THEREFORE A MANUFACTURING RECORD EVALUATION IS NOT REQUIRED. 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

    PRODUCT COMPLAINT # (B)(4). 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER SCOPE PROCEDURE THE GRYPHON P BR DS ANCHOR W/ORTHOCORD THE SURGEON NOTICED THAT THE SUTURES WERE KNOTTED, THE SURGEON UNTANGLED THE SUTURE BY USING A GRASPER BUT DAMAGED THE SUTURE IN THE PROCESS. 5 MINUTES DELAY REPORTED. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129624 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 210813 6L19048 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1