BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX

    MDR report key: 15762173 · Received November 9, 2022

    Report

    Report Number
    8030965-2022-09551
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 19, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    10886982066886
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. REPORTER IS A J&J EMPLOYEE. PART # 03.008.009, SYNTHES LOT # 1891912, SUPPLIER LOT # 1891912, RELEASE TO WAREHOUSE DATE: 12 JUNE 2008, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 THE AIM ARM FOR TI CANN HINDFOOT ARTHRO NL, P/N: 03.008.009, WAS RETURNED IN AN ASSEMBLED CONDITION WITH THRD ALIGNMENT PIN F/HINDFOOT ARTHRO NL, P/N: 03.008.004. NO SIGNIFICANT DAMAGE WAS OBSERVED ON THE SURFACE OF THE AIMING ARM. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO NOT BEING APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS PERFORMED BUT IT WAS NOT POSSIBLE TO DISASSEMBLE THE ALIGNMENT PIN. THE COMPLAINT CONDITION WAS REPLICATED. A POTENTIAL CAUSE CAN NOT BE DETERMINED SINCE IT WAS NOT POSSIBLE TO DISASSEMBLE THE DEVICES. 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 AIM ARM FOR TI CANN HINDFOOT ARTHRO NL, P/N: 03.008.009 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? YES, REVIEWED. DIMENSIONAL INSPECTION: N/A. 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, UPON ROUTINE INSPECTION PRIOR TO THE CASE, THE SALES CONSULTANT WAS ASSEMBLING THE AIMING ARM WHEN THE THREADED ALIGNMENT PIN BECAME STUCK IN THE AIMING ARM. ALL ATTEMPTS TO SEPARATE THEM WAS UNSUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432249 AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 03.008.009 1891912 10886982066886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown THRD ALIGNMENT PIN F/HINDFOOT ARTHRO NL| UNK - GUIDES/SLEEVES/AIMING: AIMING ARM