BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLING SCREW FOR INSERTION OF DHS BLADES

    MDR report key: 6676446 · Received June 29, 2017

    Report

    Report Number
    9612488-2017-10293
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Report Date
    October 30, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    UDI-DI
    10886982076984
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: A VISUAL INSPECTION UNDER 5X MAGNIFICATION, FUNCTIONAL TEST, DRAWING REVIEW, AND DIMENSIONAL ANALYSIS WERE PERFORMED AS PART OF THIS INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED WITH THE LIMITED COMPLAINT DETAILS. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. PER THE EARLIEST DRAWING REVISION, THE ASSEMBLED DEVICE SHOULD MEASURE 376MM. THE FULL LENGTH OF THE RETURNED DEVICE WAS APPROXIMATELY 362.9MM MEANING THAT THE DEVICE WAS MISSING APPROXIMATELY 13.1 MILLIMETERS OF THE DISTAL TIP. THE BROKEN FRAGMENT WAS NOT RETURNED WITH THE COMPLAINT. 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

    REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PHONE NUMBER: (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 03.224.007, LOT # 9001624: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 02.OCT.2014: NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 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

    WHEN THE DEVICE WAS RECEIVED BY THE MANUFACTURER, IT WAS NOTED THAT THE DEVICE HAD A BROKEN DISTAL TIP; THE BROKEN PORTION WAS NOT RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A COUPLING SCREW FOR INSERTION OF DHS BLADES THAT WAS REPORTEDLY BROKEN. THIS IS REPORT 21 OF 25 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458832 COUPLING SCREW FOR INSERTION OF DHS BLADES MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 9001624 10886982076984

    Patients

    Seq Age Sex Outcome Treatment
    1