BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 12005658 · Received June 15, 2021

    Report

    Report Number
    2939274-2021-02989
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Report Date
    May 22, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. H10 ADDITIONAL NARRATIVE: THE AIMING ARM/ RADIOLUCENT (P/N: 03.043.029, LOT #: 2023518) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE LATCH ON THE DEVICE WAS OBSERVED TO BE BROKEN. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. THE COMPLAINT CONDITION IS CONFIRMED FOR THE RETURNED DEVICE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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 HISTORY LOT ==> PART: 03.043.029. LOT: 2023518. MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 18 SEPTEMBER 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    THIS REPORT IS FOR ONE (1) AIMING ARM/ RADIOLUCENT. THIS REPORT IS FOR 1 OF 2 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PMA/510K: THIS REPORT IS FOR AN UNK - GUIDES/SLEEVES/AIMING: AIMING ARM/PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED; AND THE UDI NUMBER IS UNKNOWN. COMPLAINANT DEVICE/PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 AN UNKNOWN DATE, THE ATTACHMENT CLIP ON THE AIMING ARM FOR THE TNA BROKE WHILE IT WAS ATTACHED TO THE INSERTION HANDLE DURING NAIL INSERTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: UNKNOWN INSERTION HANDLE (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1), UNKNOWN NAIL (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) UNK GUIDES/SLEEVES/AIMING: THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895857 AIMING ARM/ RADIOLUCENT GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2023518

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INSERTION HANDLE| UNKNOWN NAIL