BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8245494 · Received January 14, 2019

    Report

    Report Number
    1221934-2018-54197
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    March 3, 2016
    Report Date
    March 10, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CORRECTION: METHOD CODE: THE METHOD CODE FOR THE NONCONFORMANCE SEARCH/QUERY STATEMENT WAS INADVERTENTLY MISSED IN THE INITIAL REPORT AND HAS BEEN UPDATED ACCORDINGLY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    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. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION UNDER MAGNIFICATION CONFIRMS THAT THE ANCHOR IS BROKEN ON THE PROXIMAL 1/3RD PORTION. TYPICALLY, ANCHOR BREAKAGES ARE ASSOCIATED WITH OFF -AXIS INSERTION, LEVERING DURING INSERTION OR HARD BONE QUALITY. NO TECHNIQUE INFORMATION WAS PROVIDED THAT WOULD SUGGEST IF THE AFOREMENTIONED CAUSES CONTRIBUTED TO THIS EVENT. ALTHOUGH THE COMPLAINT CAN BE CONFIRMED, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT, NO FURTHER ACTION IS WARRANTED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210813-LOT #3797068 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. 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. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A BANKART REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BODY OF THE ANCHOR BROKE AT PLACEMENT ACCORDING TO THE REPORTER, THE ANCHOR BROKE AT THE PROXIMAL AREA OF THE ANCHOR. ALL DEBRIS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH A TWO MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    38849 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3797068 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1