BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES

    MDR report key: 6614759 · Received June 6, 2017

    Report

    Report Number
    1719045-2017-10532
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    07611819393967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS CONFIRMED. THIS ISSUE HAS BEEN IDENTIFIED AND ESCALATED FROM A PREVIOUS COMPLAINT. APPROPRIATE ACTIONS HAVE BEEN INITIATED/TAKEN TO ADDRESS THE MATTER. 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 USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER EMAIL, ADDRESS, AND PHONE NUMBER ARE NOT AVAILABLE. PART 03.114.001, SYNTHES LOT H160606: RELEASE TO WAREHOUSE DATE: DECEMBER 30, 2016. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS 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 THE DRILL GUIDE COULD NOT BE INSERTED IN TO THE PLATE HOLE. NO DELAY IN THE SURGERY WAS REPORTED. CONCOMITANT PART: PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395527 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES GUIDE FZX SYNTHES MONUMENT H161606 07611819393967

    Patients

    Seq Age Sex Outcome Treatment
    1