BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS

    MDR report key: 9583105 · Received January 13, 2020

    Report

    Report Number
    8030965-2020-00317
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Report Date
    December 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819160361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. G5: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. H3, H6: INVESTIGATION SUMMARY COMPLAINED ISSUE, THAT THE IMPACTOR WAS SEIZED/JAMMED WITH THE NAIL, COULD BE CONFIRMED BASED ON THE AVAILABLE PICTURES. PRODUCT WAS NOT RETURNED. 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 (INFORMATION OR/AND MATERIAL), THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT PART: 03.010.000, LOT: L820621, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: JUNE 25, 2018. 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 · 0

    PRODUCT COMPLAINT # (B)(4). 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. E1: REPORTERS STATE: VICTORIA. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART: 03.010.000, LOT: L820621, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 25 JUNE 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.,PART: 03.010.000, LOT: L820621, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 25 JUNE 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: INVESTIGATION SUMMARY COMPLAINED ISSUE, THAT THE IMPACTOR WAS SEIZED/JAMMED WITH THE NAIL, COULD BE CONFIRMED BASED ON THE AVAILABLE PICTURES. 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. INVESTIGATION SELECTION INVESTIGATION SITE: CQ ZUCHWIL, SELECTED FLOW: FUNCTIONAL. VISUAL INSPECTION: THE RECEIVED EXTRACTION SCREW IS JAMMED/SEIZED WITH THE TITANIUM CANNULATED TIBIAL NAIL-EX AS COMPLAINED. BOTH DEVICES SHOW DEEP SCRATCHES AND IMPRESSION MARKS ON SEVERAL POINTS (PLEASE SEE IN ATTACHED DOCUMENT: INVESTIGATION PICTURES (B)(4)). IN THE NAIL HOLES ARE STILL BONE PARTS, WHICH COULD NOT BE REMOVED BY CLEANING. FUNCTIONAL TEST: THE PARTS COULD NOT BE SEPARATED, CONSEQUENTLY AN ACCURATE FUNCTIONAL TEST COULD NOT BE PERFORMED. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS CANNOT BE VERIFIED, AS THE DEVICES CANNOT BE SEPARATED ANYMORE. ACCORDING TO THE MANUFACTURING DOCUMENTS THE M8 THREADS OF BOTH LOTS PASSED THE INSPECTION STEPS DURING MANUFACTURING WITHOUT ANY DEVIATIONS. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. SUMMARY: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THE HAMMER MARKS AT THE BOTTOM SIDE OF THE EXTRACTION SCREW GIVES US AN INDICATION THAT EXCESSIVE FORCE DESCRIBES: USE THE HAMMER GUIDE 357.220 AND COMBINED HAMMER, 700G 03.010.056 TO EXTRACT THE NAIL WITH GENTLE HAMMER BLOWS. THE EXTRACTION SCREW IS RATHER INTENDED TO PREVENT ROTATION OR DISPLACEMENT OF THE NAIL. FINALLY, WE DETERMINE THAT THE CAUSE OF THIS COMPLAINT IS CONSISTENT WITH INADEQUATE HANDLING OF THE DEVICE AND IT'S THUS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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 · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS A SYNTHES SALES CONSULTANT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THAT A NAIL EXTRACTION TOOL HAS SEIZED INTO THE NAIL. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43762 CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS EXTRACTOR HWB OBERDORF SYNTHES PRODUKTIONS GMBH L820621 07611819160361

    Patients

    Seq Age Sex Outcome Treatment
    1