BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 7931065 · Received October 3, 2018

    Report

    Report Number
    1221934-2018-54796
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 3, 2018
    Report Date
    September 4, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. INVESTIGATION SUMMARY - THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, A PHYSICAL EVALUATION CANNOT BE CONDUCTED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. FURTHERMORE, A NONCONFORMANCE SEARCH WAS PERFORMED AND NO NONCONFORMACNES WERE IDENTIFIED FOR THIS PART: 210813 WITH LOT: L421804 COMBINATION. THIS COMPLAINT FILE IS BEING CLOSED, SHOULD ANY NEW INFORMATION BE RECEIVED IN THE FUTURE, THIS FILE WILL BE REOPENED AT THAT TIME AND UPDATED TO REFLECT THE INFORMATION RECEIVED. AT THIS 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 TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THE COMPLAINT CAN BE CONFIRMED. IT WAS OBSERVED THAT THE DISTAL TIP OF THE ANCHOR WAS BROKEN. ANCHOR BREAKAGES ARE TYPICALLY ASSOCIATED WITH OFF AXIS INSERTION, LEVERING DURING INSERTION, HARD BONE QUALITY OR USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE. HOWEVER, GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. A NON-CONFORMANCE SEARCH WAS CONDUCTED TO INVESTIGATE ANY DEFECTS DURING PRODUCTION IDENTIFIED THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. AT THIS POINT, 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. UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE AFFILIATE VIA E-MAIL THAT DURING A RESIDUAL SHOULDER DISLOCATION, THE ANCHOR 3.0 BROKE DURING INTRODUCTION INTO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A RESIDUAL SHOULDER DISLOCATION, THE ANCHOR 3.0 (PRODUCT: 210813, LOT: L421804) BROKE DURING INTRODUCTION INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772971 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L421804 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1