BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER REELX STT

    MDR report key: 2141584 · Received May 31, 2011

    Report

    Report Number
    2936485-2011-00374
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPAIRING THE PERONEAL TENDON WITH TISSUE MEND, THE SURGEON USED A DRILL BIT TO CREATE A PILOT HOLE FOR THE ANCHOR. AFTER DRILLING TO THE APPROPRIATE LASER LINE, THE SURGEON THEN PASSED THE SUTURE THROUGH THE TENDON WITH FORCE FIBER SUTURE. THE SURGEON THEN LOADED THE SUTURE INTO THE ANCHOR. AT THAT POINT THE SURGEON ADVANCED THE ANCHOR INTO THE PILOT HOLE AND BEGAN TO MALLET THE ANCHOR INTO THE BONE. AFTER TAPPING WITH THE MALLET THE ANCHOR WOULD ADVANCE APPROX 3/4 OF THE WAY INTO THE BONE. UPON SUBSEQUENT TAPS WITH THE MALLET, THE ANCHOR WOULD NOT ADVANCE ANY FURTHER INTO THE BONE. AT THIS POINT 1/2 THE LENGTH OF THE ANCHOR BROKE AWAY FROM THE INSERTER. APPROX 1/2 OF THE ANCHOR REMAINED IN THE BONE AND THE OTHER 1/2 WAS REMOVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER REELX STT ANCHOR MBI STRYKER ENDOSCOPY SAN JOSE 02K1003610

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR