BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3944487 · Received July 18, 2014

    Report

    Report Number
    1719045-2014-10320
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER PHONE NUMBER: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THERE WERE NO MATERIAL REVIEW RECORDS, NONCONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES ASSOCIATED WITH THIS COMPLAINT. 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)(4) AS FOLLOWS: THE THREADS AT THE END OF THE INSTRUMENT HAVE BROKEN/SNAPPED OFF. IT IS UNKNOWN HOW OR WHEN THIS HAPPENED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421173 LOCKING HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 6921274

    Patients

    Seq Age Sex Outcome Treatment
    1