BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE HOOK 45 DEG LEFT, LIMITED REUSE

    MDR report key: 1220878 · Received October 29, 2008

    Report

    Report Number
    1017294-2008-00328
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED THIS SUTURE HOOK FOR EVALUATION, AND CONFIRMED THE REPORTED PROBLEM. A VISUAL EXAMINATION FOUND THE TIP DETACHED FROM THE SUTURE HOOK, AND NO DAMAGE TO OTHER COMPONENTS. THE DETACHED PORTION WAS NOT RETURNED. THE CAUSES FOR THIS FAILURE MODE ARE ADDRESSED IN THE INFORMATION FOR USE (IFU): THE IFU PROVIDES THE FOLLOWING USER INFORMATION: WARNINGS: IF THE HOOK OR NEEDLE BENDS DURING USE, IMMEDIATELY DISCONTINUE USE AND DISCARD. THERE IS AN INCREASED RISK OF HOOK OR NEEDLE BREAKAGE AND UNINTENTIONAL PATIENT INJURY MAY RESULT. AVOID LATERAL STRESSES TO THE INSTRUMENTS OR DEVICE FUNCTION MAY BE COMPROMISED. THERE IS AN INCREASED RISK OF HOOK OR NEEDLE BREAKAGE AND UNINTENTIONAL PATIENT INJURY MAY RESULT. DO NOT USE IF PARTS ARE BROKEN, CRACKED OR WORN, OR DEVICE FUNCTION MAY BE COMPROMISED. THERE IS AN INCREASED RISK OF HOOK OR NEEDLE BREAKAGE AND UNINTENTIONAL PATIENT INJURY MAY RESULT. PRECAUTIONS: AVOID MECHANICAL SHOCK OR OVER STRESSING THE INSTRUMENT WHICH MAY SHORTEN THE LIFE OF THE INSTRUMENT. TO FACILITATE STERILIZATION AND PROPER FUNCTION OF THE DEVICE, CLEAN INSTRUMENTS PROPERLY AFTER EACH USE. INSTRUMENTS (HANDLE AND LIMITED REUSE HOOKS) SHOULD BE STORED IN THE SPECTRUM II STERILIZATION TRAY TO PROTECT THE FEATURES. INSTRUCTIONS FOR USE: PRIOR TO USE, ALWAYS INSPECT SUTURE NEEDLE FOR DAMAGE (I.E., WORN, DULL, BENT OR CRACKED.)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING FIRST TIME USE OF THIS SUTURE HOOK IN A SHOULDER PROCEDURE, THE TIP BROKE OFF IN THE PATIENT'S JOINT. THE SURGEON RETRIEVED THE TIP WITHOUT INJURY TO THE PATIENT AND WITH MINIMAL SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE HOOK 45 DEG LEFT, LIMITED REUSE SUTURE HOOK LXH CONMED LINVATEC NA 00188800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK