BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRACTURE AWL 90 DEGREE

    MDR report key: 1220819 · Received October 31, 2008

    Report

    Report Number
    1017294-2008-00338
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED THIS REUSABLE MICROFRACTURE AWL FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. A VISUAL EXAMINATION FOUND THE TIP OF THE AWL SHAFT BROKEN AND DETACHED. A MATERIAL HARDNESS CHECK FOUND THE SHAFT MET SPECIFICATION. THE CAUSE OF THIS FAILURE WAS UNABLE TO BE DETERMINED. THE INFO FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS TO THE USER: 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. INSPECT INSTRUMENT AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS AWL, THE TIP BROKE OFF IN THE SURGICAL SITE. THE TIP OF THE DEVICE WAS RETRIEVED WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFRACTURE AWL 90 DEGREE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HWJ CONMED LINVATEC NA 00947831

    Patients

    Seq Age Sex Outcome Treatment
    1 NK NK