BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE HOOK CRESCENT LARGE, LIMITED REUSE

    MDR report key: 1031711 · Received April 18, 2008

    Report

    Report Number
    1017294-2008-00177
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 24, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC WAS UNABLE TO VERIFY THE REPORTED PROBLEM. AT THIS TIME, THE FACILITY WILL NOT RELEASE THE DEVICE FOR EVAL. THIS DEVICE IS A LIMITED REUSE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THIS DEVICE CAUTIONS THE USER: DO NOT EXCEED FIVE PROCEDURES PER LIMITED REUSE SUTURE HOOK. AVOID LATERAL STRESSES TO THE INSTRUMENTS OR DEVICE FUNCTION MAY BE COMPROMISED AND UNINTENTIONAL PT INJURY MAY RESULT. DO NOT USE IF PARTS ARE BROKEN, CRACKED OR WORN, OR DEVICE FUNCTION MAY BE COMPROMISED. AVOID MECHANICAL SHOCK OR OVER STRESSING THE INSTRUMENT WHICH MAY SHORTEN THE LIFE OF THE INSTRUMENT. A REVIEW OF PRODUCT HISTORY FOUND SIMILAR REPORTED EVENTS WHERE THE BREAKAGE OF THE SUTURE HOOK OCCURRED AT THE CIRCUMFERENTIAL WELD, AND THE CAUSE OF FAILURE WAS DETERMINED TO BE TENSILE OVERLOAD BY THE USER. THERE ARE NO SERIOUS INJURIES RELATED TO THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP OF THIS SUTURE HOOK BROKE OFF DURING USE IN THE PT'S SHOULDER. AS A RESULT, THE PT REQUIRED A SECOND SURGERY TO REMOVE THE TIP. TO DATE, THE PT IS DOING WELL. THERE WAS NO REPORT OF SERIOUS INJURY FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE HOOK CRESCENT LARGE, LIMITED REUSE SUTURE HOOK LXH CONMED LINVATEC NA 00835799

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention