BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE WRENCH

    MDR report key: 6107142 · Received November 16, 2016

    Report

    Report Number
    1526439-2016-10851
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Report Date
    October 26, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    (B)(4). THE MONARCH TORQUE WRENCH HANDLE (PRODUCT CODE: 2770-40-510, LOT NUMBER: KM831558) WAS RETURNED TO THE CUSTOMER QUALITY UNIT (CQU) . VISUAL INSPECTION OF THE HANDLE DID NOT FIND ANY IMMEDIATELY OBSERVABLE DAMAGE TO THE INSTRUMENT. THE TORQUE SETTING COULD BE SET TO 60, 80, AND 100 INCH-POUNDS. THE HANDLE WAS SUBMITTED FOR TESTING. WHILE ALL OF THE TORQUE VALUES TAKEN WERE ABOVE THE INTENDED VALUE, ALL WERE WITHIN THE UPPER LIMIT OF THE TORQUE RANGE. THERE WERE NO ISSUES FOUND IN THE USE OF THIS INSTRUMENT. THIS TORQUE HANDLE FUNCTIONS AS INTENDED AS DOES SO WITHIN THE UPPER AND LOWER TORQUE LIMITS SET FOR THE INSTRUMENT. ALSO, THERE HAS BEEN NO DAMAGE FOUND TO THE INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS NO ROOT CAUSE ANALYSIS IS NECESSARY AT THIS TIME AS NO PRODUCT FAILURES HAVE BEEN IDENTIFIED DURING THE COURSE OF THIS INVESTIGATION. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    SET EX5B R2 WAS RETURNED FROM A HOSPITAL AND INSPECTED PER INSPECTION REQUIREMENTS (REFERENCE DEPUY INSPECTION REQUIREMENTS PROCEDURE 103243758 SECTION 10) AT THE FSL IN (B)(6) BY (B)(6) . DURING INSPECTION OF THE TORQUE DRIVER IN THE FACILITY IT WAS FOUND THAT THE TORQUE WRENCH WAS ABOVE SPECIFICATION AT THE 100 IN-LBS SETTING (VALUES COMING IN AT 112-116 IN-LBS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756327 TORQUE WRENCH WRENCH HXC DEPUY SYNTHES SPINE KM831558

    Patients

    Seq Age Sex Outcome Treatment
    1