BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE HOOK 45 DEG LEFT, LIMITED REUSE

    MDR report key: 868775 · Received June 19, 2007

    Report

    Report Number
    1017294-2007-00419
    Event Type
    Malfunction
    Date Received
    June 19, 2007
    Report Date
    May 21, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. THE NEEDLE OF THE DEVICE WAS RECEIVED WITH THE TIP DETACHED. THE OUTER TUBE WAS BENT. THE DETACHED PORTION WAS NOT RETURNED AND THEREFORE COULD NOT BE EVALUATED. CONMED LINVATEC IS UNABLE TO DETERMINE THE CAUSE OF FAILURE. THIS PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE THREE ADDITIONAL COMPLAINTS FROM THIS CUSTOMER FOR THE SAME DEVICE AND SAME FAILURE. THIS IS A LIMITED REUSE INSTRUMENT. THE OUTER TUBES ARE ALL BENT, INDICATING STRESS TO THE OUTER TUBE. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THIS DEVICE CAUTIONS THE USER: AVOID LATERAL STRESSES TO THE INSTRUMENTS OR THE DEVICE FUNCTION MAY BE COMPROMISED AND UNINTENTIONAL PATIENT 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.

    Description of Event or Problem · 1

    SPECTRUM NEEDLE BROKEN DURING OPERATION IN SOFT TISSUE. THERE WAS NO REPORT OF INJURY OR SURGICAL DELAY WITH THIS EVENT.

    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 890482

    Patients

    Seq Age Sex Outcome Treatment
    1 YR