BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL

    MDR report key: 12433166 · Received September 7, 2021

    Report

    Report Number
    2939274-2021-05204
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 9, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982075093
    PMA / PMN Number
    K120689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D7. H3, H6: PART: 03.127.009-US. LOT: 9102117. MANUFACTURING SITE: HEGENDORF. RELEASE TO WAREHOUSE DATE: 23 OCTOBER 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL (PART# 03.127.009, LOT# 9102117) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT A PIECE OF THE TIBIAL PLATE WAS BROKEN, AND THE BROKEN FRAGMENT WAS NOT RECEIVED. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. THE PROVIDED PHOTOGRAPH WAS REVIEWED AND NO ADDITIONAL ISSUES WERE OBSERVED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION FOR THE RECEIVED DEVICE WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DEVICE WAS RECEIVED BROKEN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: HWC. REPORTER IS A J&J REPRESENTATIVE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE AIMING ARM FOR THE VA PROXIMAL TIBIA PLATE SET WAS DROPPED ON THE FLOOR AND WAS BROKEN. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT AND SURGERY WAS NOT DELAYED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330315 AIM ARM FOR 3.5 VA-LCP PROXIMAL TIBIA PL PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.127.009 9102117 10886982075093

    Patients

    Seq Age Sex Outcome Treatment
    1