BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES

    MDR report key: 6900710 · Received September 28, 2017

    Report

    Report Number
    1719045-2017-10993
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 9, 2017
    Report Date
    September 10, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    07611819393967
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3008812560-08/04/2017-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. HOSPITAL TELEPHONE NOT AVAILABLE FOR REPORTING. THIS COMPLAINT IS CONFIRMED AS THE REPORTED ISSUE (DURING THE SURGERY HAD A DIFFICULTY IN CONNECTING THE DRILL SLEEVE TO THE PLATE HOLE) IS WELL KNOWN FROM PREVIOUS COMPLAINTS. RELEVANT MANUFACTURING ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS MATTER. DHR REVIEW. PART NUMBER: 03.114.001. SYNTHES LOT NUMBER: 9972971. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: (B)(6) 2017. SUPPLIER: (B)(4). (B)(4) WAS GENERATED DURING PRODUCTION FOR 4 PARTS OF 275 FOR GO GAGE DOES NOT GO. THE PRODUCT WAS DISPOSITIONED AS RETURNED. AND RE-WORKED. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. . REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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: THE REPORTED DEVICE WAS USED IN THE VETERINARIAN SURGERY. DURING A DRY RUN, THE SURGEON UNDERSTOOD THAT THERE WAS NO PROBLEM WITH CONNECTING THE DRILL SLEEVE INTO THE PLATE HOLE. HOWEVER, THE SURGEON DURING THE SURGERY HAD A DIFFICULTY IN CONNECTING THE DRILL SLEEVE TO THE PLATE HOLE. THE SURGEON COMMENTED THAT THE SLEEVE INSERTION TO THE PLATE HOLE WAS SHALLOW. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681180 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES GUIDE FZX SYNTHES MONUMENT 9972971 07611819393967

    Patients

    Seq Age Sex Outcome Treatment
    1