BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASHER 13.0MM

    MDR report key: 6215842 · Received December 30, 2016

    Report

    Report Number
    3006126083-2016-10050
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 6, 2016
    Manufacturer
    SYNTHES RARON
    Product Code
    HTN
    UDI-DI
    07611819031807
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION HAS BEEN COMPLETED FOR PART# 419.990, LOT# 9955479. ONE WASHER 13.0MM DEVICE WAS RETURNED TO MANUFACTURER FOR INVESTIGATION. A VISUAL INSPECTION AND DEVICE HISTORY RECORDS REVIEW HAS BEEN COMPLETED AS PART OF THIS INVESTIGATION. THE RECEIVED DEVICE IS BROKEN IN HALF AND THE INSIDE DIAMETER IS NOTED TO BE DEFORMED. BECAUSE OF THE DAMAGE, ONLY THE THICKNESS COULD BE CHECKED AND FOUND TO MEET THE SPECIFICATIONS. THE SPECIFICATION AS PER THE VALID TECHNICAL DRAWING AND THE MEASURED THICKNESS WITH CALIPER IS 1.49MM. THE DEVICE HISTORY RECORDS REVIEW SHOWS THAT THE DEVICE MET FULLY TO OUR SPECIFICATIONS AT THE TIME OF MANUFACTURING IN JUNE 2016 AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MANNER OF DEFORMED INSIDE DIAMETER SUGGESTS THAT THE WASHER BROKE BECAUSE OF MECHANICAL OVERLOADING. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE BROKE INTRA-OPERATIVE; DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(6). (B)(4). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUNE 08, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 A SURGERY FOR FEMORAL NECK FIXATION WAS PERFORMED ON (B)(6) 2016. AFTER THE SCREW WAS FIXED IT WAS NOTED THAT THE WASHER WAS BROKEN DURING X-RAY PHOTOGRAPHY. THE SURGEON HAD TO REMOVE THE BROKEN WASHER AND INSERT AND FIX THE SCREW AGAIN TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT TWO (2) HOURS. PATIENT CONDITION IS STABLE. CONCOMITANT REPORTED PART: SCREW (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866379 WASHER 13.0MM BOLT, NUT, WASHER HTN SYNTHES RARON 9955479 07611819031807

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention 1 UNKNOWN SCREW