BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE

    MDR report key: 9120959 · Received September 25, 2019

    Report

    Report Number
    1219602-2019-01176
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 7, 2019
    Report Date
    October 28, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7210423 ACCUPASS LEFT CURVE 45 DEGREE SUTURE SHUTTLE USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT BUT IT WAS INCONCLUSIVE. DUE TO PRODUCT UNAVAILABILITY, PHYSICAL EVALUATION, FULL INVESTIGATION AND CONCLUSIONS WERE LIMITED. FACTORS AFFECTING DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY AND SURGICAL SITE PREPARATION ACCORDING TO INSTRUCTIONS FOR USE. INSTRUCTIONS FOR USE CONFIRMS INSTRUCTIONS, RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS AND FOR PROPER USE OF PRODUCT. INFLUENCES THAT COULD COMPROMISE PRODUCT INTEGRITY INCLUDE: INADVERTENT USE OF EXCESS TORQUE OR FORCE. INCOMPATIBLE MONOFILAMENT SIZE FOR SPECIFIC SHUTTLE. INADVERTENT TWISTING OR BENDING OF THE PRODUCT. ENTANGLEMENT WITH GUIDE WIRE OR OTHER INSTRUMENT. INADVERTENT REUSE OF A SINGLE USE DEVICE. PER INSTRUCTION FOR USE: ¿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.¿ DO NOT USE THESE INSTRUMENTS AS LEVERS FOR MANIPULATING HARD TISSUE OR BONE. EXCESSIVE FORCE SHOULD NOT BE APPLIED TO THE INSTRUMENT WHEN MANIPULATING SOFT TISSUE, BONE, OR HARD OBJECTS. MISUSE OF THESE INSTRUMENTS MAY RESULT IN BENT DISTAL TIPS OR JAWS; AND DULL OR UNEVEN CUTTING EDGES.¿ FINAL PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ORANGE SHAFT BROKE AND THE METALLIC PART DETACHED INSIDE THE CANNULA. THE PROCEDURE WAS SUCCESSFULLY COMPLETE WITH A BACK UP DEVICE. THERE WAS A 1.5 HOURS DELAY REPORTED AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908436 ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 2023294 03596010534446

    Patients

    Seq Age Sex Outcome Treatment
    1