BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI HOLE WIRE GUIDE

    MDR report key: 8637367 · Received May 23, 2019

    Report

    Report Number
    8030965-2019-64460
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    10886982070166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. CORRECTED DATA: EVENT DATE. 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. H3, H4, H6- SHIPPED BACK DEVICE ¿MULTIHOLE DRILL SLEEVE¿ WITH LOT NUMBER L203835 IS IN USED CONDITIONS. THE DEVICE SHOWS MODERATE SCRATCHES AND THE PRESENCE OF SIGNS OF DAMAGE. IN PARTICULAR, ON THE TIP OF THE CENTRAL CHANNEL, THE DAMAGED MATERIAL CREATES A SMALL EDGE THAT NARROWS THE DIAMETER OF THE HOLE. THE TWO EXTERNAL CHANNELS OF THE DEVICE PASSED FUNCTIONAL TEST WITH GUIDE WIRE 3.2, GAUGE 60078828, WHILE THE CENTRAL ONE FAILED THE TEST. GUIDE WIRE 3.2 WAS INTRODUCED IN THE CENTRAL CHANNEL FROM THE BACK OF THE DEVICE. IT WAS ABLE TO PASS THROUGH THE ENTIRE CENTRAL CHANNEL, BUT IT STOPPED AFTER IT CAME OUT OF THE TIP HOLE FOR FEW MILLIMETERS. ALL THE DOCUMENTS MENTIONED ABOVE HAVE BEEN ANALYZED. THE MANUFACTURING PROCESS WAS EXECUTED ACCORDING TO THE ANALYZED DOCUMENTS AND NO ANOMALIES WERE FOUND. ACCORDING TO EVIDENCES IS NOT POSSIBLE TO ADDRESS THE FINAL ROOT CAUSE TO A MANUFACTURING ISSUE. MOST LIKELY THE DEVICE WAS USED INCORRECTLY AND THE MISHANDLING CAUSED DAMAGE TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS APPROPRIATE. DEVICE HISTORY LOT PART: 03.037.000, LOT: L203835, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 12.JAN.2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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.

    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. 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

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE MULTIHOLE WIRE GUIDE WAS NOT PERMEABLE TO THE GUIDE WIRE DURING A PRACTICAL WORKSHOP WITH THE TFNA TEAM THAT WAS HELD IN THE OFFICE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MULTI HOLE WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430336 MULTI HOLE WIRE GUIDE GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 03.037.000 L203835 10886982070166

    Patients

    Seq Age Sex Outcome Treatment
    1