BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULLSEYE AIMER 5MM

    MDR report key: 759335 · Received August 1, 2006

    Report

    Report Number
    1017294-2006-00307
    Event Type
    Malfunction
    Date Received
    August 1, 2006
    Date of Event
    July 4, 2006
    Report Date
    July 4, 2006
    Manufacturer
    CON MED LINVATEC CORPORATION
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM THE CUSTOMER'S REPORTED PROBLEM AS TO DATE THE PRODUCT HAS NOT BEEN RETURNED TO CONMED LINVATEC FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT AFTER PRODUCT IS RECEIVED AND INVESTIGATED.

    Description of Event or Problem · 1

    A PIECE OF THE INSTRUMENT REPORTEDLY SNAPPED OFF DURING ACL SURGERY. THE PIECE WAS RETRIEVED FROM THE PT'S KNEE AND DISCARDED. IT WAS REPORTED THAT NO INJURY WAS INCURRED, AND NO FURTHER TREATMENT IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BULLSEYE AIMER 5MM FEMORAL GUIDE LXH CON MED LINVATEC CORPORATION NA 27438

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN