BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 16162308 · Received January 13, 2023

    Report

    Report Number
    8030965-2023-00528
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 13, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07612334171092
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. PART # 03.043.028, LOT # 20698103, MANUFACTURING SITE: WERK SELZACH, RELEASE TO WAREHOUSE DATE: 18 DEC 2020, EXPIRATION DATE:NA, SUPPLIERS: BÄCHLER FEINTECH AG. 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. NOTE: A DRIVING CAP FROM FAMILY 03.043.028 WAS EVALUATED AND INVESTIGATED BY R&D. PLEASE REFER TO THE ATTACHMENT "MEMO CHU FOR 03.043.028 DRIVING CAP" FOR THE INVESTIGATION REPORT. IT WAS REPORTED THAT THE CROSS PIN CONNECTING THE PULL BUTTON TO THE DRIVING CAP ASSEMBLY GOT LOOSE AND THE DRIVING CAP DISASSEMBLED. RETURNED PART WAS ASSESSED BY R&D AND SENT TO MATERIALS AND TESTING. SINCE THE CROSS PIN THROUGH THE PULL BUTTON WAS NOT RETURNED THE WELD AT THE TIP OF THE PART WHICH IS MANUFACTURED BY THE SAME VENDOR WAS ASSESSED. 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 103711819 REV D 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¿. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRIVING CAP WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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: THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: REV. G (CURRENT AND MANUFACTURED). 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 SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. ADDITIONAL NARRATIVE: REPORTER IS A J&J EMPLOYEE. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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, 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

    IT WAS REPORTED THAT ON (B)(6) 2022, THE TNA IMPACTOR BROKE UPON INSERTION. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRIVING CAP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186629 DRIVING CAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 03.043.028 20698103 07612334171092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown