BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7NM RATCHETING TORQUE LIMITING HANDLE

    MDR report key: 3981282 · Received August 5, 2014

    Report

    Report Number
    1719045-2014-10354
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. AVALIGN-NEMCOMED MANUFACTURED THE 7NM TORQUE LIMITING RATCHET, P/N 03.627.017, LOT NUMBER 6601914, (SUPPLIER LOT # 6601914-22), PER PO # (B)(4), DATED (B)(4) 2011, FOR (B)(4) PARTS. THE PRODUCT CONFORMED TO ALL REQUIREMENTS AS NOTED IN THE CERTIFICATE OF COMPLIANCE, DATED (B)(4) 2011, AND WAS INSPECTED / CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION ¿C¿. THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES FOR THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2011. THE 7NM TORQUE LIMITING RATCHET WAS MADE TO THE SYNTHES DRAWING NUMBER (B)(4), REVISION ¿D¿, RELEASED ON (B)(4) 2011. ADDITIONAL RELEASE TO WAREHOUSE ON (B)(4) 2011. 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): A MANUFACTURING EVALUATION WAS COMPLETED: THE INVESTIGATION OF THE DOCUMENTATION FROM MATERIAL AND PRODUCTION SHOWS THAT THE T-HANDLE WITH RATCHET WRENCH WAS PRODUCED IN 2012 AND MEETS SPECIFICATIONS. FURTHERMORE THESE INSTRUMENTS UNDERGO FINAL INSPECTION BEFORE LEAVING THE PLANT. THEREFORE WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THE FAILURE AFTERWARDS.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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE TORQUE LIMITER WAS OUT OF SPECIFICATION. THE FAILURE WAS DETECTED AT THE ORTHO KIT DEPARTMENT IN HOUSE DURING CHECKING OF THE LOANER SET. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457764 7NM RATCHETING TORQUE LIMITING HANDLE SCREWDRIVERS HXX SYNTHES MONUMENT 6601914-22

    Patients

    Seq Age Sex Outcome Treatment
    1