BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 16618759 · Received March 27, 2023

    Report

    Report Number
    8030965-2023-03683
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 8, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    10886982297389
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: E1. H3, H4, H6: PART: 03.043.028. LOT: 21456103. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: BÄCHLER FEINTECH AG. RELEASE TO WAREHOUSE DATE:15 DECEMBER 2021. EXPIRATION DATE: NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE WAS PERFORMED ON DRIVING CAP. IT WAS REPORTED THAT THE CROSS PIN CONNECTING THE PULL BUTTON TO THE DRIVING CAP ASSEMBLY GOT LOOSE AND THE DRIVING CAP DISASSEMBLED. THE OBSERVED CONDITION OF THE PIN HAS BEEN PREVIOUSLY ASSESSED BY MATERIALS AND TESTING. MATERIALS AND TESTING PROVIDED DRAFTED REPORT THAT SHOWED SOME DEFICIENCIES IN THE WELD. CONCLUSION FROM R&D WAS THAT ALTHOUGH THE WELD MIGHT NOT BE PERFECT THERE MUST BE SOME SIGNIFICANT LOAD LEADING TO THE FAILURE OF THE WELD. MATERIALS AND TESTING SUBSEQUENTLY PERFORMED A FINITE ELEMENT ANALYSIS TO INVESTIGATE ORIGIN OF STRESS AT THE INTERFACE BETWEEN CROSS PIN AND PULL BUTTON. ANALYSIS SHOWED THAT STRONG OFF AXIS HAMMER BLOWS CAN LEAD TO OSCILLATIONS IN THE SYSTEM THAT CAN CAUSE STRESS THAT CAN LEAD TO BREAKAGE OF THE LASER WELD AT THE END OF THE PIN AND SUBSEQUENT MIGRATION. SURGICAL TECHNIQUE GUIDE MENTIONS ¿APPLY LIGHT AND CONTROLLED HAMMER BLOWS TO SEAT THE NAIL¿ AND ¿THE HAMMER GUIDE MAY AID IN CONTROLLING THE DIRECTION OF THE HAMMER BLOWS. THEREFORE, THE HAMMER GUIDE CAN BE ATTACHED TO THE BACK END OF THE DRIVING CAP BY SCREWING BOTH PARTS TOGETHER¿. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE DRIVING CAP. BASED ON THE TESTING PERFORMED BY MATERIALS AND TESTING, THE ROOT CAUSE CAN BE DETERMINED TO BE TRACED TO THE USER. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED. CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. 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. D9. G1.

    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. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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 · 0

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF SURGERY USING TNA FOR LEFT TIBIAL SHAFT FRACTURE WITH THE DRIVING HEAD IN QUESTION. IN THE SURGERY, THE FRONT SPRING CAME OFF DURING NAIL INSERTION BY HAMMERING. THIS DID NOT AFFECT NAIL INSERTION AND CONTINUED HAMMERING. AFTER THEY REMOVED THE INSERTION HANDLE AFTER FIXING THE PLATE ON PROXIMAL PORTION, THEY CHECKED THE DRIVING HEAD AND FOUND IT WAS PINNED IN FROM THE SIDE. WHEN THE SURGICAL FIELD WAS CHECKED, THE DETACHED PIN HAD FALLEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR A DRIVING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431274 DRIVING CAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 03.043.028 21456103 10886982297389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - NAIL INSERTION HANDLES| UNK - NAILS| UNK - PLATES: TRAUMA