BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON PEEK W/PROKNOT

    MDR report key: 8206261 · Received December 31, 2018

    Report

    Report Number
    1221934-2018-55877
    Event Type
    Injury
    Date Received
    December 31, 2018
    Date of Event
    December 27, 2018
    Report Date
    December 28, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705024049
    PMA / PMN Number
    K140643
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE EXP DATE IS CURRENTLY UNAVAILABLE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED BY THE CUSTOMER THE IMPLANT DEVICE WAS LEFT EMBEDDED IN THE PATIENT'S BONE THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. IT WAS REPORTED THAT THE SUTURE BRIDGE IS DAMAGED. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART#: 210821 LOT#:1L85497 COMBINATION AND NO NONCONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION THE CUSTOMER'S GRYPHON PEEK ANCHOR WITH PROKNOT UNLOADED WHILE PULLING THE INSERTER OUT. THE SALES REP STATED THAT THE CARD WAS STILL ATTACHED TO ONE END AND THE FREE END DIDN'T GET PULLED THROUGH THE ANCHOR. THE SALES REP STATED THAT IT SEEMED LIKE THE SUTURE BRIDGE ON THE ANCHOR WAS DEFECTIVE. THE CASE WAS COMPLETED WITH ANOTHER ANCHOR IN A DIFFERENT LOCATION WITH A ONE MINUTE DELAY. THE SALES REP STATED THERE IS NO NEED FOR SURGICAL INTERVENTION. THE SALES REP STATED THAT OTHER ANCHORS IN THE SAME LOT HAD NO PROBLEMS, BUT THE SALES REP DID NOT PROVIDE A LOT NUMBER. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS A PROLONGED HOSPITALIZATION. THE PATIENT'S STATUS POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045958 GRYPHON PEEK W/PROKNOT SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MAI DEPUY MITEK LLC US 1L85497 10886705024049

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention