BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE

    MDR report key: 3894207 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12093
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED AND NO LOT NUMBER PROVIDED. 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: AT THE DISTAL LOCKING, THE SCREW WAS INSERTED THROUGH THE PROTECTION SLEEVE, HOWEVER, THE SCREW WAS MISALIGNED. THE SURGEON SLIGHTLY APPLIED TENSION TO THE PROTECTION SLEEVE AND THE SCREW WAS INSERTED WITHOUT PROBLEM, THE MULTILOC HUMERAL NAILS (04.016.034S) WERE USED FOR A PROXIMAL HUMERAL BONE FRACTURE CASE. NO REPORTED PATIENT HARM. THIS REPORT IS 3 OF 5 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370448 12.0MM/8.0MM PROTECTION SLEEVE MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1