BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT

    MDR report key: 5973486 · Received September 23, 2016

    Report

    Report Number
    1719045-2016-10704
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 23, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). PART 388.393 LOT 6101570 (SYNTHES LOT): RELEASE TO WAREHOUSE DATE: MARCH 16, 2009. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION; REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT, PART NUMBER 388.393, LOT NUMBER 593436E08). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING THAT DURING THE SURGERY, THE REPORTED DRILL GUIDE WAS NOT FUNCTIONING PROPERLY. THE SURGEON TRIED TO ADJUST THE GAUGE; HOWEVER, THE STOPPER WAS NOT FUNCTIONING AND THE GAUGE WAS SLIDING. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE AS THE SURGEON USED THE DRILL SLEEVE CAUTIOUSLY. POST-OPERATIVELY IT WAS FOUND THAT THE STOPPER WAS NOT FUNCTIONING AT ALL AND IT THEN IT CRACKED WHEN HE TOUCHED. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCE WAS REPORTED. WHEN THE DEVICE WAS RECEIVED BY THE MANUFACTURER, IT WAS NOTED THAT THE DEVICE WAS BROKEN. IT WAS CONFIRMED AT THE DEVICE BROKE DURING TRANSIT. IT WAS ONLY CRACKED AFTER THE PROCEDURE AND BROKEN BY THE TIME IT WAS RECEIVED BY THE MANUFACTURER. AS PREVIOUSLY REPORTED, THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE SUBJECT DEVICE LOT WAS RELEASED IN MARCH 2009 AFTER FAULTLESS FINAL INSPECTION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION REVEALED THAT THE WELDING JOINT IS BROKEN AND THEREFORE THE PARTS ARE COMPONENTS. THE WELDING AREA HOWEVER LOOKS COMPLETE AND NO IRREGULARITY COULD BE IDENTIFIED. FUNCTIONAL TESTING OF THE COMPONENTS SHOWS THAT ALL MOVABLE PARTS ARE STILL IN GOOD CONDITION. BECAUSE OF THE BROKEN CONNECTION USE OF THE INSTRUMENT IS NO LONGER POSSIBLE. AS THIS INSTRUMENT HAS BEEN IN USE SINCE MARCH 2009, IT IS LIKELY THAT INADEQUATE HANDLING MAY HAVE CAUSED THE BREAKAGE. THE COMPLAINT CONDITION IS CONFIRMED ALTHOUGH THE EXACT ROOT CAUSE OF THE BREAKAGE COULD NOT BE DETERMINED BASED ON THE REPORTED INFORMATION. NO PRODUCT FAULT COULD BE IDENTIFIED. NO INDICATION FOR MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE WAS FOUND. 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 XXX AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY, THE REPORTED DRILL GUIDE WAS NOT FUNCTIONING PROPERLY. THE SURGEON TRIED TO ADJUST THE GAUGE; HOWEVER, THE STOPPER WAS NOT FUNCTIONING AND THE GAUGE WAS SLIDING. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE AS THE SURGEON USED THE DRILL SLEEVE CAUTIOUSLY. POST-OPERATIVELY IT WAS FOUND THAT THE STOPPER WAS NOT FUNCTIONING AT ALL AND IT THEN IT CRACKED WHEN HE TOUCHED. THERE WAS A TEN (10) MINUTES SURGICAL DELAY. NO ADVERSE CONSEQUENCE WAS REPORTED. WHEN THE DEVICE WAS RECEIVED BY THE MANUFACTURER, IT WAS NOTED THAT THE DEVICE WAS BROKEN. IT WAS CONFIRMED AT THE DEVICE BROKE DURING TRANSIT. IT WAS ONLY CRACKED AFTER THE PROCEDURE AND BROKEN BY THE TIME IT WAS RECEIVED BY THE MANUFACTURER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624396 DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT GUIDE FZX SYNTHES MONUMENT 593436E08

    Patients

    Seq Age Sex Outcome Treatment
    1