BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5NM TORQUE LIMITING HANDLE WITH QC

    MDR report key: 6049148 · Received October 21, 2016

    Report

    Report Number
    2520274-2016-15030
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 3, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.127.016, LOT# 9984251. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: MAY 03, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    MANUFACTURING EVALUATION AND PRODUCT DEVELOPMENT INVESTIGATION HAVE BEEN COMPLETED. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW AND MANUFACTURING INVESTIGATION WERE PERFORMED AS PART OF THIS INVESTIGATION. UPON RECEIPT OF THE TORQUE INSTRUMENT, THE TORQUE WAS CHECKED WITHIN SPECIFICATION AT 6.544NM/6.793NM. SPECIFICATION IS 6.00NM TO 6.84NM. THE TORQUE INSTRUMENT WAS WITHIN THE SPECIFIED TOLERANCE BUT OUT OF CALIBRATION. ACCORDING TO OUR RECORDS THIS DEVICE WAS MANUFACTURED IN JUNE OF 2016 AND HAS NOT BEEN SERVICED THROUGHOUT THE LIFE OF THE PART. THIS DEVICE REQUIRES ROUTINE RE-CALIBRATION SERVICE IN ORDER FOR IT TO MAINTAIN TORQUE OUTPUT THAT IS WITHIN THE SPECIFIED TOLERANCE. IT IS SUGGESTED THAT THIS DEVICE BE RE-CALIBRATED ONCE EVERY 6 MONTHS. BASED ON THESE DETERMINATIONS, THIS REPORTED FAILURE IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESSES AT TECOMET. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. 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

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON NOTICE THAT THE TORQUE LIMITER SEEMED HIGHER THEN THE 2.5 NM THAT IT SHOULD BE. RISK FOR DESTROYING THE SCREW. THIS COMPLAINT INVOVLES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700335 2.5NM TORQUE LIMITING HANDLE WITH QC SCREWDRIVERS HXX SYNTHES MONUMENT 9984251

    Patients

    Seq Age Sex Outcome Treatment
    1