BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE

    MDR report key: 10123574 · Received June 5, 2020

    Report

    Report Number
    1219602-2020-00846
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 7, 2020
    Report Date
    August 5, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010534446
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: ONE 7210423 ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE USED IN TREATMENT WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT CONFIRMS THE COMPLAINT. THE INFORMATION PROVIDED STATES THAT ¿DURING A SHOULDER ARTHROSCOPY SURGERY THE FRONY HEAD OF THE ACCU-PASS BROKE OFF WHEN THE SUTURE HOOK IS INSERTED, ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER¿. VISUAL ASSESSMENT SHOWED A CUT MONOFILAMENT. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE IMPROPER USE OF DEVICE. THE INSTRUCTION FOR USE WAS REVIEWED AND WAS FOUND TO OUTLINE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. .¿ ROLLING THE WHEELS FORWARD AND BACKWARD MAY INITIATE TANGLING OR WRAPPING OF THE MONOFILAMENT AROUND THE WHEELS. THE ROLLER WHEELS PERFORM BEST WITH CONTINUOUS MOVEMENT IN THE SAME DIRECTION. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE FRONY HEAD OF THE ACCU-PASS BROKE OFF WHEN THE SUTURE HOOK IS INSERTED, ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER. NO DELAY WAS REPORTED. SURGERY WAS FINISHED WITH THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586051 ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 2036649 03596010534446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other