BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8064536 · Received November 13, 2018

    Report

    Report Number
    1221934-2018-55271
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 23, 2018
    Report Date
    October 23, 2018
    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 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. THE MANUFACTURER CONTACT NAME HAS BEEN UPDATED AS KARA DITTY-BOVARD. CONTACT PHONE NUMBER AND EMAIL ADDRESS HAVE BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY: THE DEVICE IS NOT BEING RETURNED. THE DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION AND HENCE THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART(210813), LOT(L790121) COMBINATION AND NO NONCONFORMANCES WERE FOUND. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4)-INCOMPLETE ASSOCIATED MEDWATCH: 1221934-2018-55270.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHORS WERE BROKEN AND BENT WHEN THE SURGEON INSERTED TO THE PATIENT¿S KNEE ON (B)(6) 2018. ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT¿S BODY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION FROM THE AFFILIATE RECEIVED ON (B)(6) 2018 STATED THAT THE PATIENT'S BONE QUALITY WAS HARD AND NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE PROCEDURE OR THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907137 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L790121 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1