BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONG ANGL-UPWARDS W/4 L330

    MDR report key: 3233549 · Received July 18, 2013

    Report

    Report Number
    8030965-2013-04357
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN ADDITIONAL EVALUATION WAS CONDUCTED BY SYNTHES (B)(4) AND THE REPORT INDICATES: DEVICE WAS INSPECTED AND VISUAL EXAMINATION CONFIRMED PART OF THE TIP HAD BROKEN OFF. THE SURGEON NOTICED THE BROKEN TIP PRIOR TO SURGERY AND ALTHOUGH THE EXACT CAUSE FOR THE BROKEN TIP COULD NOT BE CONFIRMED, THE DAMAGE IS MOST LIKELY THE RESULT OF MISHANDLING DURING PREVIOUS SURGERY OR DURING MAINTENANCE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR THE SAME EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE SURGEON ATTEMPTED TO USE THE RONGEUR AND NOTED IT WAS DAMAGED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335615 RONG ANGL-UPWARDS W/4 L330 HTX SYNTHES GMBH T954830

    Patients

    Seq Age Sex Outcome Treatment
    1