BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE

    MDR report key: 9189207 · Received October 14, 2019

    Report

    Report Number
    1219602-2019-01235
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 16, 2019
    Report Date
    January 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
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7210424 ACCUPASS 45 DEGREE SUTURE SHUTTLE USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. THERE ARE SCRATCHES ON THE TIP AS WITH CONTACT WITH ANOTHER DEVICE OR INSTRUMENT. INTEGRITY WAS COMPROMISED BY FORCE. THE DISTAL TIP WAS DISTORTED AND SPLIT OPEN. THIS TYPICALLY OCCURS WHEN INADVERTENT LEVERAGE IS APPLIED. FACTORS AFFECTING DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY AND SURGICAL SITE PREPARATION ACCORDING TO INSTRUCTIONS FOR USE, WHICH PROVIDES RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS AND FOR PROPER USE OF PRODUCT. PER IFU: ¿IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ASSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCES CAN RESULT IN FAILURE OF THE INSTRUMENT.¿ PLEASE NOTE: ADVANCEMENT OF THE MONOFILAMENT REQUIRES BACKWARD ROTATION OF THE ROLLER WHEEL TOWARD THE USER. KEEPING LIGHT TENSION ON THE TAIL OF THE FILAMENT ASSISTS THE ROLLER FEED SMOOTHLY. LOT AND COMPLAINT REVIEW WERE COMPLETED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ONE 7210424 ACCUPASS 45 DEGREE SUTURE SHUTTLE USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, PHYSICAL EVALUATION, FULL INVESTIGATION WERE LIMITED. A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. FACTORS AFFECTING DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY AND SURGICAL SITE PREPARATION ACCORDING TO INSTRUCTIONS FOR USE (IFU). INFLUENCES THAT COULD COMPROMISE PRODUCT INTEGRITY INCLUDE: 1) ROLLING THE MONOFILAMENT ADVANCEMENT ROLLER WHEELS BACK AND FORTH. 2) INADVERTENT TWISTING OR BENDING OF THE PRODUCT. 3) ENTANGLEMENT WITH GUIDE WIRE OR OTHER INSTRUMENT. 4) INADVERTENT USE OF EXCESS TORQUE OR FORCE. 5) INCOMPATIBLE MONOFILAMENT SIZE FOR SPECIFIC SHUTTLE. 6) INADVERTENT REUSE OF A SINGLE USE DEVICE. PER IFU: ¿IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ASSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCES 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. PLEASE NOTE: MONOFILAMENT ADVANCES WITH ROTATION OF WHEELS IN A BACKWARD DIRECTION TOWARD THE USER. KEEPING LIGHT TENSION ON THE TAIL OF THE FILAMENT HELPS THE ROLLER FEED SMOOTHLY. PLEASE NOTE: MONOFILAMENT ADVANCES WITH ROTATION OF WHEELS IN A BACKWARD DIRECTION TOWARD THE USER. KEEPING LIGHT TENSION ON THE TAIL OF THE FILAMENT HELPS THE ROLLER FEED SMOOTHLY. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL PROCEDURE THE DEVICE TIP BROKE. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979507 ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 2035625 03596010534453

    Patients

    Seq Age Sex Outcome Treatment
    1