BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 13895351 · Received March 24, 2022

    Report

    Report Number
    2939274-2022-01053
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 24, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982297389
    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

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: H3, H4, H6: PART 03.043.028, LOT 20228902: MANUFACTURING SITE: SELZACH. SUPPLIER: BÄCHLER FEINTECH AG. RELEASE TO WAREHOUSE DATE: MARCH 15, 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL ANALYSIS OF THE RETURNED SAMPLE WAS PERFORMED ON THE 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. RETURNED PART WAS ASSESSED BY RESEARCH AND DEVELOPMENT (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. THE 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. 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 DURING A PROCEDURE ON (B)(6), 2022, THE RETAINING PIN RELEASE STARTED TO COME OUT WHILE IMPLANTING THE NAIL. PROCEDURE WAS COMPLETED WITH NO DELAY. PATIENT OUTCOME WAS STABLE. 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
    1053215 DRIVING CAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.043.028 20228902 10886982297389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - NAILS