BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE

    MDR report key: 6380748 · Received March 6, 2017

    Report

    Report Number
    1719045-2017-10187
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 10, 2017
    Report Date
    February 10, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. UDI: (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 03.507.002S, LOT # H102573: RELEASE TO WAREHOUSE DATE: 18-JULY-2016, EXPIRATION DATE: 30-JUNE-2025, SUPPLIER: (B)(4). NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A THREADED REDUCTION TOOL BROKE DURING A MIDFACE ORBIT FRACTURE REPAIR ON (B)(6) 2017. AS THE SURGEON WAS REDUCING THE FRACTURE, THE 2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE BROKE CLOSE TO THE BALL ABOVE THE THREADS. THE THREADED PIECE WAS REMOVED WITH THE BROKEN SCREW SET TREPHINE REAMER AND EXTRACTION PIECE. THERE WAS A REPORTED APPROXIMATE FIVE (5) MINUTE SURGICAL DELAY FOR BROKEN PIECE REMOVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164571 2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT H102573

    Patients

    Seq Age Sex Outcome Treatment
    1