BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE

    MDR report key: 10054724 · Received May 14, 2020

    Report

    Report Number
    1219602-2020-00781
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    April 22, 2020
    Report Date
    June 8, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010534453
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ONE 7210424 ACCU-PASS STR SHUTTLE 45 DEG RIGHT CURVE USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. THE INFORMATION PROVIDED STATES THAT ¿DURING SHOULDER PROCEDURE THE ACCU-PASS WAS NOT ROLLED IN THE DEVICE¿. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE, EXCESSIVE FORCE. INSTRUCTIONS FOR USE: CONFIRMS INSTRUCTIONS, RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. PER INSTRUCTIONS FOR USE: ¿AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN FAILURE OF THE INSTRUMENT.¿ 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. 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 SHOULDER PROCEDURE THE ACCU-PASS WAS NOT ROLLED IN THE DEVICE. IT WAS FOUND EXTERNAL TO THE PATIENT. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS 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
    523100 ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 2040027 03596010534453

    Patients

    Seq Age Sex Outcome Treatment
    1