BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG, CINCHLOCK SS ANCHOR WITH INSERTER

    MDR report key: 11346550 · Received February 18, 2021

    Report

    Report Number
    0002936485-2021-00102
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    November 10, 2020
    Report Date
    March 1, 2021
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    UDI-DI
    07613252633228
    PMA / PMN Number
    K131769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: THE SURGEON DEPLOYED 4X CINCHLOCK SS ANCHORS (CAT02462) INTO PATIENT. TWO OF THE ANCHORS FAILED. I BELIEVE THEY FAILED BECAUSE THE SUTURES BROKE THROUGH THE ANCHOR. NEITHER OF THE ANCHORS PULLED OUT OF THE BONE. UPDATE 17 NOVEMBER 2020: 30 MINUTE SURGICAL DELAY. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE: 1) INCOMPLETE LEVER ACTUATION, 2) EXCESSIVE FORCE APPLIED TO SUTURE, OR 3) USER NOT FAMILIAR WITH DEVICE USE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. NO PIECES WERE LEFT IN THE JOINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. NO PIECES WERE LEFT IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242274 FG, CINCHLOCK SS ANCHOR WITH INSERTER FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE CAT02462 20072AE2 07613252633228

    Patients

    Seq Age Sex Outcome Treatment
    1