BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE

    MDR report key: 9519676 · Received December 26, 2019

    Report

    Report Number
    1219602-2019-01627
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    November 28, 2019
    Report Date
    April 17, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010534446
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: THE ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE P/N 7210423 WAS NOT RETURNED FOR EVALUATION. WITHOUT THE REPORTED PRODUCT, A VISUAL AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND THE CUSTOMER¿S COMPLAINT CANNOT BE CONFIRMED. THE INFORMATION PROVIDED STATES THAT ¿THAT DURING A SURGICAL PROCEDURE, AN ACCU-PASS LEFT 45 ° WAS USED TO PASS THE SUTURE POINTS OF THE ANCHOR IN THE "LABRUM" TISSUE. WHEN THE POINT WAS PASSED, THE ACCU-PASS WAS ROLLED SO THAT THE MONOFILAMENT CAME OUT, IT WAS RECOVERED BUT WHEN PULLING IT, ONLY HALF CAME OUT BECAUSE IT WAS LOCKED AND IT DID NOT ADVANCE ANYMORE. WHEN TRYING TO REMOVE THE ACCU-PASS FROM THE TISSUE WITHOUT THE MONOFILAMENT, THE TISSUE WAS TORN AND AN ANCHOR POINT WAS LOST¿. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: ¿IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS 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. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF COMPLAINTS AND MANUFACTURING BATCH RECORDS WAS PREFORMED, SIMILAR COMPLAINTS OF THIS FAILURE MODE WERE FOUND.

    Additional Manufacturer Narrative · 0

    H10 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 ¿THAT DURING A SURGICAL PROCEDURE, AN ACCU-PASS LEFT 45 ° WAS USED TO PASS THE SUTURE POINTS OF THE ANCHOR IN THE "LABRUM" TISSUE. WHEN THE POINT WAS PASSED, THE ACCU-PASS WAS ROLLED SO THAT THE MONOFILAMENT CAME OUT, IT WAS RECOVERED BUT WHEN PULLING IT, ONLY HALF CAME OUT BECAUSE IT WAS LOCKED AND IT DID NOT ADVANCE ANYMORE. WHEN TRYING TO REMOVE THE ACCU-PASS FROM THE TISSUE WITHOUT THE MONOFILAMENT, THE TISSUE WAS TORN AND AN ANCHOR POINT WAS LOST¿. 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. A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS WAS PERFORMED AND INDICATED SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AN ACCU-PASS LEFT 45 ° WAS USED TO PASS THE SUTURE POINTS OF THE ANCHOR IN THE "LABRUM" TISSUE. WHEN THE POINT WAS PASSED, THE ACCU-PASS WAS ROLLED SO THAT THE MONOFILAMENT CAME OUT, IT WAS RECOVERED BUT WHEN PULLING IT, ONLY HALF CAME OUT BECAUSE IT WAS LOCKED AND IT DID NOT ADVANCE ANYMORE. WHEN TRYING TO REMOVE THE ACCU-PASS FROM THE TISSUE WITHOUT THE MONOFILAMENT, THE TISSUE WAS TORN AND AN ANCHOR POINT WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY AS A RESULT OF THE DEVICE MALFUNCTION. 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
    1316241 ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 7210423 50802116 03596010534446

    Patients

    Seq Age Sex Outcome Treatment
    1