BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG UP

    MDR report key: 10497512 · Received September 4, 2020

    Report

    Report Number
    1219602-2020-01360
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    July 29, 2020
    Report Date
    October 9, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010534460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6 H10: ONE 7210425 ACCU-PASS STR SHUTTLE 45 DEG UP USED IN TREATMENT WAS RETURNED FOR EVALUATION. THE INFORMATION PROVIDED STATES THAT ¿DURING THE PROCEDURE USING A ACCU-PASS 45-DEGREE, UPBEND, STERILE WHEN THE NEEDLE WAS INSERTED INTO THE MENISCUS, THE MONOFILAMENT WOULD NOT COME OUT¿. VISUAL ASSESSMENT SHOWED A CUT MONOFILAMENT. THE INSTRUCTION FOR USE (IFU 1061583) 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. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. THE PRODUCT FAMILY IS UNDER REVIEW. OCCURRENCE RATE OF ALLEGATIONS ARE MONITORED VIA SURVEILLANCE. IN ADDITION, A CORRECTIVE ACTION HAS BEEN INITIATED TO INVESTIGATE THIS FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE USING AN ACCU-PASS 45-DEGREE, WHEN THE NEEDLE WAS INSERTED INTO THE MENISCUS, THE MONOFILAMENT WOULD NOT COME OUT; THEREFORE, IT WAS NOT ABLE TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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
    961047 ACCU-PASS STR SHUTTLE 45 DEG UP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 7210425 2044731 03596010534460

    Patients

    Seq Age Sex Outcome Treatment
    1