BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE

    MDR report key: 11694925 · Received April 20, 2021

    Report

    Report Number
    0002936485-2021-00215
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 22, 2021
    Report Date
    May 26, 2021
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    UDI-DI
    37613327464819
    PMA / PMN Number
    K181083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: IN COMPLETING AN ARTHROSCOPIC BICEPS TENODESIS, A 1.4MM TAPE LOOP SUTURE (3910-900-043) WAS INSERTED INTO 4.75 EYELET, AND INTO HARD BONE AT TOP OF BICEPS GROOVE. IN FOLLOWING WITH 4.75 SCREW, THE SCREW WOULD NOT ADVANCE AND WAS DESCRIBED AS BEING ¿STRIPPED¿. WHEN THE SCREW WAS PULLED BACK, THE SCREW WAS BROKEN MID-BODY. TAPS OR DRILLS NOT USED FOR OMEGA. WE OPENED A NEW 3.9MM OMEGA SCREW AND PLACED SUCCESSFULLY WITH SUFFICIENT PURCHASE AND FIXATION. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE: 1) USE OF EXCESSIVE FORCE, 2) USER DOES NOT DRILL/TAP PILOT HOLE, 3) USER DOES NOT GO TO LASER LINE (INCOMPLETE TAPPING/DRILLING/AWLING), 4) USE OF INCORRECT DRILL SIZE FOR ASSOCIATED SCREW, OR 5) INADEQUATE ASSESSMENT OF BONE QUALITY. PLEASE NOTE THAT THE INITIAL REPORT'S TYPE OF REPORTABLE EVENT WAS SERIOUS INJURY, BUT THROUGH THE INVESTIGATION IT WAS CONFIRMED THAT THE BROKEN PIECES DID NOT REMAIN IN THE PATIENT. THEREFORE MAKING THIS EVENT A MALFUNCTION. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    PLEASE NOTE THAT THE INITIAL REPORT'S TYPE OF REPORTABLE EVENT WAS SERIOUS INJURY, BUT THROUGH THE INVESTIGATION IT WAS CONFIRMED THAT THE BROKEN PIECES DID NOT REMAIN IN THE PATIENT. THEREFORE MAKING THIS EVENT A MALFUNCTION.

    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 SCREW BROKE DURING THE PROCEDURE AND REMAINS IN THE PATIENT. NOTE, THE PIECE OF THE BROKEN SCREW THAT REMAINS IN THE PATIENT IS SECURELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593448 OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE 20317AG2 37613327464819

    Patients

    Seq Age Sex Outcome Treatment
    1 Other