BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM

    MDR report key: 3521023 · Received December 16, 2013

    Report

    Report Number
    2520274-2013-07786
    Event Type
    Malfunction
    Date Received
    December 16, 2013
    Date of Event
    November 19, 2013
    Report Date
    November 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE, JDW. DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A FEMORAL NECK PINNING PROCEDURE, THE SURGEON EXPERIENCED A PROBLEM WITH THE GUIDE WIRE AND 6.5 CANNULATED SCREW. THE 6.5 CANNULATED SCREW GOT STUCK OVER THE GUIDE WIRE. WHEN REMOVING THE GUIDE WIRE THE SCREW CAME OUT WITH IT. THERE WAS A 5 MINUTE DELAY IN COMPLETING THE PROCEDURE. THE DELAY WAS DUE TO REMOVING THE SCREW AND INSERTION OF THE NEW GUIDE WIRE AND SCREW. IT WAS DISCOVERED POST OPERATIVELY THAT THE GUIDE WIRE WAS BENT AND NOT NOTICED DURING INSERTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658017 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR