BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED PIN HEADLESS 3.2MM X 63MM

    MDR report key: 1456518 · Received May 29, 2009

    Report

    Report Number
    3005673311-2009-00008
    Event Type
    Malfunction
    Date Received
    May 29, 2009
    Date of Event
    February 7, 2009
    Report Date
    May 27, 2009
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PIECES OF DEVICE THAT WERE NOT RETAINED WERE DISCARDED. EVALUATION OF THE DEVICE INVOLVED IN THE INCIDENT IS NOT POSSIBLE. PATIENT HAS NOT REPORTED ANY ADVERSE SYMPTOMS / EVENTS DUE TO THE ISSUE. SURGEON REPORTED VIA AESCULAP SALES REPRESENTATIVE THAT HE DOES NOT THINK RETAINED PIECES ARE GOING TO BE A PROBLEM. AESCULAP SALES REPRESENTATIVE WAS AWARE OF THE COMPLAINT BEFORE (B)(4) 2009, REPORT TO QA, BUT DID NOT KNOW THE INCIDENT NEEDED TO BE REPORTED WHEN IT OCCURRED; HOWEVER, HAS SINCE BEEN TRAINED ON COMPLAINT REPORTING. AESCULAP IMPLANT SYSTEMS TREND INFORMATION INDICATES THERE HAS NOT BEEN ANOTHER COMPLAINT INVOLVING THIS ITEM IN THE TWENTY-FOUR MONTHS PRIOR TO THIS REPORT. WE WILL CONTINUE TO MONITOR AND TREND FOR OCCURRENCES OF THIS NATURE.

    Description of Event or Problem · 1

    (B)(6) WAS USING THE SCREWS IN A KNEE CARE. TWO PINS FROM THE SET WERE BROKEN IN HALF WHEN NORMAL PRESSURE WAS APPLIED. UNABLE TO RETRIEVE BROKEN PIECES; ITEMS RETAINED IN PATIENT. BROKEN PIECES DISCARDED IN SURGERY. NO PATIENT INJURY OR PROLONGING OF SURGERY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREADED PIN HEADLESS 3.2MM X 63MM LXH AESCULAP AG & CO. KG NP583R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other