BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL, MICROFRACTURE, 45 DEGREES

    MDR report key: 1674534 · Received April 28, 2010

    Report

    Report Number
    1017294-2010-00057
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 29, 2010
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED THIS AWL FOR EVAL. A VISUAL EXAMINATION CONFIRMED THE REPORTED PROBLEM AND FOUND THE AREA OF BREAKAGE BENT IN THE WRONG DIRECTION. THIS TYPE OF DAMAGE IS SEEN IF THE DEVICE IS USED AS A LEVER OR EXCESSIVE FORCE IS APPLIED DURING USE. A 2 YEAR REVIEW OF DEVICE HISTORY SHOWS NO OTHER REPORTS FOR THIS FAILURE MODE. THE INFO FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS: INSPECT INSTRUMENT PRIOR TO USE TO ENSURE IT IS IN GOOD PHYSICAL CONDITION AND FUNCTIONS PROPERLY. THERE SHOULD BE NO LOOSE, BROKEN OR MISALIGNED PARTS. EXERCISE CARE IN THE USE OF THE DEVICE TO MINIMIZE SIDE OR BENDING LOADS. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE. IN ADDITION, THE USER IS INFORMED TO ALWAYS INSPECT AND TEST THE INSTRUMENT FOR PROPER FUNCTION PRIOR TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS AWL TO PERFORM AN ARTHROSCOPIC HIP PROCEDURE, THE TIP OF THIS INSTRUMENT BROKE INSIDE THE SURGICAL SITE. THE TIP WAS RETRIEVED BY USING A GRASPER FORCEPS, WHICH RESULTED IN A DELAY OF ABOUT 10 MINUTES. THE PROCEDURE WAS COMPLETED AS INTENDED WITHOUT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AWL, MICROFRACTURE, 45 DEGREES ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HWJ CONMED LINVATEC 00118908

    Patients

    Seq Age Sex Outcome Treatment
    1