BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE

    MDR report key: 10230285 · Received July 3, 2020

    Report

    Report Number
    1219602-2020-00985
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    June 11, 2020
    Report Date
    August 17, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: B5:EVENT DESCRIPTION UPDATED D4: UDI INFORMATION ADDEDADDED EXPIRATION DATE ADDED D10: UPDATE TO NO, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION H4: DEVICE MANUFACTURE DATE ADDED.

    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:1) INADVERTENT TWISTING OR BENDING OF THE PRODUCT. 2) ENTANGLEMENT WITH GUIDE WIRE OR OTHER INSTRUMENT. 3) INADVERTENT USE OF EXCESS TORQUE OR FORCE. 4) INCOMPATIBLE MONOFILAMENT SIZE FOR SPECIFIC SHUTTLE. 5) 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.¿ 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. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION ALTHOUGH FAILURE OCCURRENCE DROVE ADDITIONAL INVESTIGATION. INITIAL FINDINGS PRODUCED ACCEPTABLE RESULTS. SURVEILLANCE IS ONGOING. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PRODUCT WAS UNPACKED FOR A KNEE ARTHROSCOPY FOR LIGAMENTOPLASTY, IT WAS IMPOSSIBLE TO GET THE WIRE OUT, IT WAS VERY DIFFICULT TO HANDLE THE ROULETTE WHEEL. THERE WAS BACKUP DEVICE AVAILABLE AND A SIGNIFICANT DELAY WAS REPORTED, NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY FOR LIGAMENTOPLASTY, IT WAS IMPOSSIBLE TO GET THE WIRE OUT, IT WAS VERY DIFFICULT TO HANDLE THE ROULETTE WHEEL. IT IS UNKNOWN IF THERE WAS A DELAY OR IF THERE WAS BACKUP DEVICE AVAILABLE. NO PATIENT INJURIES 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
    694381 ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 2025232

    Patients

    Seq Age Sex Outcome Treatment
    1