BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM DRILL BIT/MQC/75MM

    MDR report key: 3951765 · Received July 23, 2014

    Report

    Report Number
    1719045-2014-10333
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    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. ADDITIONAL MANUFACTURER RELEASE DATE (B)(4) 2013. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. ORCHID UNIQUE MANUFACTURED THE 1.1MM DRILL BIT/MQC/75MM, PART NUMBER 03.114.007, AND LOT NUMBER U180798 FOR POS 1566478 AND 1570905. THE SUPPLIER¿S CERTIFICATES OF COMPLIANCE (DATED (B)(4) 2013 FOR TWO SEPARATE RECEIPTS OF THIS LOT) INDICATE THE PARTS WERE MANUFACTURED TO P/N 03.114.007, REVISION ¿C¿ AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION ¿E¿ (COMPLETED (B)(4) 2013). NO NONCONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE HISTORY RECORD REVIEW REVEALED THAT THE MEASURABLE DIMENSIONS OF THE RETURNED DRILL BITS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE MANUFACTURING PAPERS (ONLY FOR DRILL BIT 03.114.007 AS OTHER LOT NUMBER IS UNKNOWN) SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. OUR INVESTIGATIONS HAVE SHOWN THAT BOTH DRILL BITS ARE INDEED COMPLETELY BROKEN OFF (03.114.007 ON THE TIP AND 513.005 ON THE SHAFT). AS MENTIONED ON THE DEVICE REPORT THE SURGEON MAY HAVE APPLIED TOO MUCH FORCE DURING DRILLING WHICH RESULTED IN THESE BREAKAGES. UNFORTUNATELY NO FURTHER INFORMATION HAD BEEN MADE AVAILABLE. WE ARE AWARE OF THE FACT THAT THESE ARE RATHER DELICATE INSTRUMENT WHICH CAN BREAK IF TOO MUCH FORCE IS APPLIED. NO PRODUCT FAULT COULD BE DETECTED. 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 TWO DRILL BITS BROKE WHILE DRILLING WITH A 4.0 NM TORQUE LIMITER. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THIS REPORT IS FOR THE 2ND OF THE 2 BROKEN DRILL BITS THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429881 1.1MM DRILL BIT/MQC/75MM BIT, DRILL HTW SYNTHES MONUMENT U180798

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR