BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT

    MDR report key: 4720753 · Received April 22, 2015

    Report

    Report Number
    1719045-2015-10238
    Event Type
    Malfunction
    Date Received
    April 22, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 7, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MANUFACTURE DATES: MAR 23, 2009, MAR 24, 2009 AND APR 7, 2009. THIS NOTE WAS MISTAKENLY REPORTED AS NOTE D2 IN H10 OF THE INITIAL REPORT. 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. ADDITIONAL NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED BY THE REPORTER. ADDITIONAL DEVICE MANUFACTURE DATES: MAR 23, 2009, MAR 24, 2009 AND APR 7, 2009. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 601642N08. THE REPORTED LOT NUMBER IS A VENDER LOT NUMBER AND CORRESPONDS WITH SYNTHES LOT NUMBERS 6101571, 6110182, 6110185 AND 6114620. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. LOT 6101571 WAS RELEASED 3/10/09, LOT 6110182 WAS RELEASED 3/23/09, LOT 6110185 WAS RELEASED 3/24/09, AND LOT 6114620 WAS RELEASED 4/7/09. THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (PART NUMBER 388.393, LOT NUMBER 601645N08, DRILL SLEEVE). THE INVESTIGATION OF THE DRILL SLEEVE HAS SHOWN THAT THE SHAFT BROKEN OFF FROM HANDLE. THE INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN DEVICE WAS MANUFACTURED IN MARCH 2009. THE DEVICE WAS USED MANY TIMES. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE THEREFORE, IT IS LIKELY THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE. THE SHAFT AND THE SLEEVE HAVE HEAVY STRESS MARKS. THESE ARE CLEAR SIGNS THAT THIS INSTRUMENT WAS SUBJECTED TO TREMENDOUS FORCES AND THIS COULD LEAD TO THE BREAKAGE OF WELD. 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) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE GUIDE BROKE AFTER DRILLING WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT OR SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267495 DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT GUIDE FZX SYNTHES MONUMENT 601645N08

    Patients

    Seq Age Sex Outcome Treatment
    1