BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE

    MDR report key: 9696182 · Received February 11, 2020

    Report

    Report Number
    1219602-2020-00194
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 9, 2020
    Report Date
    April 3, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010534453
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE 7210424 ACCU-PASS STR SHUTTLE 45 DEG RIGHT CURVE USED IN TREATMENT WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT CONFIRMS COMPLAINT. DEVICE RETURNED WITH MONOFILAMENT. ROLLER WAS TESTED AND CONFIRMS COMPLAINT. THE INFORMATION PROVIDED STATES THAT ¿DURING SHOULDER INSTABILITY SURGERY, THE DOCTOR MENTIONED THAT IT WAS HARD TO PULL IN AND OUT THE NYLON MONOFILAMENT THROUGH THE SHARP TIP. SOMETIMES IT WORKED PROPERLY AND SOMETIMES IT DID NOT¿. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SHOULDER INSTABILITY SURGERY, THE DOCTOR MENTIONED THAT IT WAS HARD TO PULL IN AND OUT THE NYLON MONOFILAMENT THROUGH THE SHARP TIP. SOMETIMES IT WORKED PROPERLY AND SOMETIMES IT DID NOT. THEN, HE USED ANOTHER INSTRUMENT (NOT FROM S&N) FOR THE SAME PURPOSE. THE PROCEDURE WAS COMPLETED BY USING A SIXER AND A CLEVER HOOK. THE DEVICE WAS FROM (B)(4). NO DELAY OR 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
    157431 ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 7210424 2038978 03596010534453

    Patients

    Seq Age Sex Outcome Treatment
    1