BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA Ø11 125° L240 TAN

    MDR report key: 4093844 · Received September 16, 2014

    Report

    Report Number
    2520274-2014-13673
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES: HWC. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT FOR DISTAL LOCKING DID NOT PASS THROUGH THE CANNULATION OF THE NAIL INSTEAD IT STRUCK THE NAIL. THE SURGEON HAD TO REMOVE THE AIMING ARM AND PERFORM FREEHAND LOCKING. THERE WERE NO REPORTS OF A SURGICAL DELAY OR PATIENT HARM. THIS REPORT IS 6 OF 6 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571568 PFNA Ø11 125° L240 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1