BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 3962261 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12861
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS AN INSERTION HANDLE, PART AND LOT NUMBER UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE TIP SIDE (BLACK PART) OF CONNECTOR FOR INSERTION HANDLE WAS BROKEN WHEN INSERTING INTO THE INSERTION HANDLE, IT WAS REPORTED TO BE INSERTED CORRECTLY. THIS REPORT IS FOR AN INSERTION HANDLE, PART AND LOT NUMBER UNKNOWN THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439604 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1