BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEG CURVE LEFT, QUICKPASS LASSO

    MDR report key: 19385260 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03765
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    March 7, 2022
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867038950
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING. AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED.

    Description of Event or Problem · 0

    ON 03/07/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-6068-90L 90°, CURVE, LEFT, QUICKPASS LASSO HAD AN ISSUE. THE SURGEON WAS PERFORMING A POSTERIOR LABRAL REPAIR OF A RIGHT SHOULDER ON (B)(6) 2022. A 90 CURVE LEFT QUICKPASS LASSO WAS OPENED TO PASS SUTURES IN THE 6 O'CLOCK POSITION. OUT OF THE PACKAGE, THE SCRUB TECH TRIED TO EXPEL THE NITINOL GUIDE WIRE, BUT IT WOULD NOT COME OUT THE TIP. THE SCRUB TECH THEN TOOK THE NITINOL GUIDE WIRE OUT OF THE PASSER AND TRIED TO LOAD THE PASSER AGAIN, BUT AGAIN IT WOULD NOT EXPEL OUT OF THE TIP. AFTER NUMEROUS ATTEMPTS, A SECOND 90 DEGREE CURVE LEFT QUICKPASS LASSO WAS OPENED. THIS LASSO HAD A SMALL AMOUNT OF NITINOL GUIDE WIRE HANGING OUT THE TIP, SO THIS WAS PULLED THROUGH THE TIP COMPLETELY AND TRIED TO RELOAD IT BUT THE PASSER ONCE AGAIN DID NOT EXPEL THE SUTURE. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A CONMED SPECTRUM. THIS WAS DISCOVERED DURING THE UNBOXING OF THE COMPLAINT DEVICE WITH NO CASE/PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12158 90 DEG CURVE LEFT, QUICKPASS LASSO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 90 DEG CURVE LEFT, QUICKPASS LASSO 1274116122 00888867038950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown