BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON T ANCHOR

    MDR report key: 2021374 · Received February 8, 2011

    Report

    Report Number
    1221934-2011-00045
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 7, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, THE DISTAL TIP OF THE INSERTER BROKE IN THE ANCHOR UPON INSERTION. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE, AND THE SURGEON DID NOT USE PROPER PROTOCOL AS STATED IN THE IFU: HE DID NOT TAP THE BONE HOLE AS INDICATED IN THE IFU. THE ROOT CAUSE FOR THE DEVICE FAILURE IS MOST LIKELY THE FAILURE TO PROPERLY PREP THE BONE HOLE BY TAPING IT, WHICH WOULD FACILITATE THE ANCHOR INSERTION. THIS MOST LIKELY LED TO THE NEED TO USE EXCESSIVE ROTATIONAL MECHANICAL FORCE WHILE ATTEMPTING TO DEPLOY THE ANCHOR INTO THE BONE HOLE. THE FRAGMENT REMAINS WITHIN THE ANCHOR CAPTURED IN THE BONE. ALTHOUGH THE FRAGMENT WAS NOT RETRIEVED FROM THE BODY, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRYPHON T ANCHOR SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK 210812 3325778

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK