BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL SHAFT

    MDR report key: 3963139 · Received July 29, 2014

    Report

    Report Number
    3000270450-2014-10054
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    FZO
    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. (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: END PIECE OF THE MILLING BIT IS BROKEN OFF. THE MILLING BIT IS IN A VERY USED CONDITION. THE RELEVANT DIMENSIONS OF THE MILLING BIT WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING, DIMENSIONS MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD (1.4197). THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED. THIS LOT WAS MANUFACTURED IN JUNE 2008. OUR INVESTIGATION HAS SHOWN THAT THE MILLING BIT IS IN A VERY USED CONDITION, THERE ARE STRESS MARKS ALL OVER THE SHAFT AND THE COUPLING PIECE. THE CUTTING EDGES OF THE BROKEN END PIECE ARE COMPLETELY BLUNT, THIS MAKES IT SEEM LIKELY THAT EITHER A METALLIC CONTACT, PAR EXAMPLE WITH THE GUIDE, OR THE USE OF A BLUNT INSTRUMENT CAUSED THE BREAKAGE OF THIS DEVICE. 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 THAT THE END PIECE OF THE MILLING BIT SNAPPED IN THE MILLING GUIDE WHILE IN USE. THE KEEL WAS NOT CUT CORRECTLY AND THE SURGEON HAD TO TRY AGAIN. THE SURGEON WAS ALSO CONCERNED THAT THE FRAGMENT HAD DAMAGED THE DURA, HOWEVER AFTER INVESTIGATION NO DAMAGE WAS DONE. THERE WAS NO PATIENT HARM. THE SURGERY WAS PROLONGED TWENTY MINUTES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440952 CHISEL SHAFT CHISEL,SURGICAL INSTRUMENT FZO SYNTHES SELZACH 346114F1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR