BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1

    MDR report key: 3516018 · Received December 11, 2013

    Report

    Report Number
    2520274-2013-07590
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Report Date
    November 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE HTY. THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF DEVICE HISTORY RECORDS WAS NOT PERFORMED, NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2013; DURING THE UNKNOWN SURGERY THE GUIDE WIRE BROKE AWAY WHILE OVER-DRILLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649356 GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1 LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1