BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMOFIX OSTEOT CHISEL W/15

    MDR report key: 9354313 · Received November 21, 2019

    Report

    Report Number
    8030965-2019-70463
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 6, 2019
    Report Date
    November 6, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZO
    UDI-DI
    07611819275713
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART: 397.993, LOT: 9962525, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 12.SEPTEMBER 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THIS COMPLAINT IS CONFIRMED. THE RETURNED CHISEL WAS RECEIVED BROKEN AS REPORTED. THE SECTION OF THE PROXIMAL EDGE HAS BROKEN OFF. FURTHERMORE, THE DEVICE IS IN A VERY USED CONDITION WITH SCRATCHES AND IMPRESSION MARKS. DIMENSIONAL INSPECTION: THE WIDTH OF THE RETURNED CHISEL ADJACENT TO THE LOCATION OF BREAKAGE MEASURED 20.06MM AT CQ WHICH IS WITHIN SPECIFICATION OF 20.0MM +/-0.2MM. THE THICKNESS OF THE RETURNED CHISEL ADJACENT TO THE LOCATION OF BREAKAGE MEASURED 2.97MM AT CQ WHICH IS WITHIN SPECIFICATION OF 3.0MM +/-0.1MM. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING DOCUMENT SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. (B)(4). THE BROKEN SURFACE IS HOMOGENEOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. SUMMARY: THE RECEIVED CONDITION OF THE COMPLAINT AGREES WITH THE COMPLAINT DESCRIPTION SINCE THE SCREW IS BROKEN AS CLAIMED BY THE CUSTOMER. THUS, THE COMPLAINT IS RATED AS CONFIRMED. ALTHOUGH A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED, THE MOST LIKELY CAUSE FOR THIS COMPLAINT IS EXCESSIVE HAMMERING WHICH RESULTED IN ULTIMATE BREAKAGE OF THE DEVICE. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE'S. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.,INVESTIGATION SELECTION. INVESTIGATION SITE: ZUCHWIL. SELECTED FLOW: DAMAGED - BROKEN. VISUAL INSPECTION: THIS COMPLAINT IS CONFIRMED. THE RETURNED CHISEL WAS RECEIVED BROKEN AS REPORTED. THE SECTION OF THE PROXIMAL EDGE HAS BROKEN OFF. FURTHERMORE, THE DEVICE IS IN A VERY USED CONDITION WITH SCRATCHES AND IMPRESSION MARKS. DIMENSIONAL INSPECTION: THE WIDTH OF THE RETURNED CHISEL ADJACENT TO THE LOCATION OF BREAKAGE MEASURED WHICH IS WITHIN SPECIFICATION. THE THICKNESS OF THE RETURNED CHISEL ADJACENT TO THE LOCATION OF BREAKAGE MEASURED DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING DOCUMENT SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE USED MATERIAL WAS STAINLESS STEEL (B)(4) AS REQUIRED AND THE MEASURED HARNESS WAS WITH 54.5 ¿ 54.9 WITHIN THE SPECIFICATION OF 52-56 HRC FROM DRAWING SE_420729 REVISION B. THE BROKEN SURFACE IS HOMOGENEOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. SUMMARY: THE RECEIVED CONDITION OF THE COMPLAINT AGREES WITH THE COMPLAINT DESCRIPTION SINCE THE SCREW IS BROKEN AS CLAIMED BY THE CUSTOMER. THUS, THE COMPLAINT IS RATED AS CONFIRMED. ALTHOUGH A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED, THE MOST LIKELY CAUSE FOR THIS COMPLAINT IS EXCESSIVE HAMMERING WHICH RESULTED IN ULTIMATE BREAKAGE OF THE DEVICE. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART: 397.993. LOT: 9962525. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: SEPTEMBER 12, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED., PART: 397.993, LOT: 9962525. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: SEPTEMBER 12, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019 DURING A HTO PROCEDURE, WHEN ATTEMPTING TO REMOVE OSTEOTOME, THE LIP ON THE END OF OSTEOTOME BROKE OFF. FRAGMENTS WERE EASILY REMOVED. NO SURGERY DELAY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, NO CONSEQUENCE TO THE PATIENT. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148974 TOMOFIX OSTEOT CHISEL W/15 CHISEL,SURGICAL INSTRUMENT FZO OBERDORF SYNTHES PRODUKTIONS GMBH 9962525 07611819275713

    Patients

    Seq Age Sex Outcome Treatment
    1