BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 16818237 · Received April 26, 2023

    Report

    Report Number
    8030965-2023-05315
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    January 16, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07612334171092
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J SALES REPRESENTATIVE. PART#: 03.043.028, LOT#: 21616601, MANUFACTURING SITE: WERK SELZACH LOGISTIK, RELEASE TO WAREHOUSE DATE: 19 MAY 2022, SUPPLIER: BÄCHLER FEINTECH AG, EXPIRATION DATE: N/A. 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 WAS EVALUATED AND INVESTIGATED BY R&D. PLEASE REFER TO THE ATTACHMENT "MEMO CHU FOR DRIVING CAP" FOR THE INVESTIGATION REPORT. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DRIVING CAP HAD THE CROSS PIN LOOSE AND PARTIALLY PULLED OUT, THE LOWER PIN IS MISSING, THIS IS DUE TO THE LASER WELD LINE BEING BROKEN ON THE EDGES OF BOTH PINS. ADDITIONALLY, THE DEVICE PRESENTS SIGNS OF IMPACTION ALONG THE SURFACE OF THE KNOB. 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¿. A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE DRIVING CAP AND MET SPECIFICATIONS. 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: THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: DRIVING CAP REV. G / REV. G, CYLINDR-PIN Ø3 0 REV. D / REV. D. DIMENSIONAL INSPECTION: DRAWING: SPECIFIED DIMENSIONS: DIAMETER OF THE RETENTION PIN. MEASURED DIMENSIONS: DIAMETER OF THE RETENTION PIN = (CONFORMING). DEVICE USED: 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) 2023 THE CONNECTING PIN COMING LOOSE ON IMPACTOR, AIMING ARM FAILED TO ACCURATELY TARGET THE LOCKING SCREWS IN THE PROXIMAL PORTION OF THE NAIL. THEY HIT THE NAIL WITH THE DRILL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 2 OF 2 FOR COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080711 DRIVING CAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 21616601 07612334171092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AIMING ARM/ RADIOLUCENT