BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE

    MDR report key: 10151369 · Received June 13, 2020

    Report

    Report Number
    1219602-2020-00900
    Event Type
    Injury
    Date Received
    June 13, 2020
    Date of Event
    May 20, 2020
    Report Date
    August 11, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7210423 ACCU-PASS 45 DEGREE LEFT CURVE SUTURE SHUTTLE DEVICE USED FOR TREATMENT BUT WAS NOT RETURNED FOR EVALUATION. DUE TO UNAVAILABILITY, EVALUATION WAS LIMITED. INSTRUCTION FOR USE (IFU) CONTAINS PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY AND SURGICAL SITE PREPARATION ACCORDING TO INSTRUCTIONS FOR USE (IFU). INFLUENCES THAT COULD COMPROMISE PRODUCT INTEGRITY INCLUDE: INADVERTENT TWISTING OR BENDING OF THE PRODUCT. ENTANGLEMENT WITH GUIDE WIRE OR OTHER INSTRUMENT. INADVERTENT USE OF EXCESS TORQUE OR FORCE. INCOMPATIBLE MONOFILAMENT SIZE FOR SPECIFIC SHUTTLE. INADVERTENT REUSE OF A SINGLE USE DEVICE. PER IFU 1061583: ¿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.¿ PRODUCT MET PREDETERMINED SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW INDICATED NO CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. PLEASE NOTE: MONOFILAMENT ADVANCES WITH ROTATION OF WHEELS BACKWARD TOWARD THE USER. KEEPING LIGHT TENSION ON THE TAIL OF THE FILAMENT HELPS THE ROLLER FEED SMOOTHLY. RESULTS AND PROBABLE CAUSE WERE DRAWN, DETERMINED OR CONCLUDED BASED UPON FILES SUCH AS MANUFACTURING DOCUMENTATION, DHR, COMPLAINT HISTORY, IFU, RISK MANAGEMENT, CLINICAL/MI RESULTS, MATERIAL ASSESSMENT AND TECHNIQUE GUIDES (AS APPLICABLE). NO INDICATION SUGGESTS PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE ACCUPASS TIP BROKE WHEN IT WAS PASSED THROUGH THE LABRAL TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO 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
    615118 ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 2046702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention