BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG UP

    MDR report key: 10212262 · Received June 30, 2020

    Report

    Report Number
    1219602-2020-00964
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 15, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7210425 ACCU-PASS STR SHUTTLE 45 DEG UP USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. VISUAL ASSESSMENT CONFIRMS COMPLAINT. MONOFILAMENT WOULD NOT ADVANCE THROUGH ACCU-PASS. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE, EXCESSIVE FORCE. IFU CONFIRMS INSTRUCTIONS, RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. 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 SURGERY, THE MONOFILAMENT WOULD NOT COME OUT OF THE ACCU-PASS HENCE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP 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
    677607 ACCU-PASS STR SHUTTLE 45 DEG UP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 7210425 2040029 03596010534460

    Patients

    Seq Age Sex Outcome Treatment
    1