BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.9MM TI LOCKING BOLT 38MM

    MDR report key: 15380981 · Received September 8, 2022

    Report

    Report Number
    8030965-2022-06549
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K970733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. ADDITIONAL PRODUCT CODES: JDN, JDS, HTY, AND JDW. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. PART: 459.38. LOT: 5941048. RELEASE TO WAREHOUSE DATE: 05 DEC 2016. MANUFACTURING SITE: WERK SELZACH. 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. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT BOLT Ø4.9 SELF-TAP L38 TAN GREEN, HAS STRIPPED IN THE HEAD SCREW. NO OTHER PROBLEMS OR DEFECTS WERE FOUND. A DIMENSIONAL INSPECTION COULD NOT BE PERFORMED FOR THE BOLT Ø4.9 SELF-TAP L38 TAN GREEN, DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE BEING CONSISTENT WITH RANDOM COMPONENT FAILURE WHICH MAY HAVE BEEN CAUSED BY EXPOSURE TO UNWANTED FORCES AS MENTIONED IN THE DESCRIPTION OF THE EVENT. 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 BOLT Ø4.9 SELF-TAP L38 TAN GREEN 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: IN (B)(6) 2022, THE PREVIOUSLY IMPLANTED DFN NAIL WAS FOUND TO HAVE BROKEN IN SITU. THIS NAIL WAS ORIGINALLY IMPLANTED IN (B)(6) 2017. ON (B)(6) 2022, SURGERY WAS PERFORMED TO EXPLANT THE BROKEN NAIL AND IMPLANT A NEW RAFN NAIL. DURING MANUFACTURER INSPECTION OF THE RETURNED DEVICES, IT WAS NOTED THE LOCKING BOLT WAS STRIPPED/WORN/TWISTED/CROSS THREADED. THIS REPORT IS FOR A LOCKING BOLT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237169 4.9MM TI LOCKING BOLT 38MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 5941048

    Patients

    Seq Age Sex Outcome Treatment
    1 Female BOLT Ø4.9 SELF-TAP L36 TAN GREEN.| DFN Ø10 CANN L360 TAN GREEN.| END-CAP F/LOCK-SCR Ø6 F/DFN TAN TURQUOIS.| SPIRAL BLADE F/DFN L60 TAN PINK.