BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM THREADED GUIDE WIRE 150MM

    MDR report key: 8873592 · Received August 8, 2019

    Report

    Report Number
    8030965-2019-66993
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LRN
    UDI-DI
    07611819733121
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 292.620S. LOT: 4L16743. MANUFACTURING SITE: SELZACH. SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG. RELEASE TO WAREHOUSE DATE: 05. APR. 2019. EXPIRY DATE: 01. APR. 2029. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT 4L02111 IN BALSTHAL AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 292.620 WITH LOT 4L02111 WERE REVIEWED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 4L02111, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: HTY. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2019, THE GUIDE WIRE 1.25MM THREADED TIP W/TROCAR SNAPPED INSIDE THE PATIENT¿S TIBIA WHEN BEING USED TO POSITION A 3.5MM CANNULATED SCREW. THERE WAS NO PATIENT INJURY. CONCOMITANT DEVICES: 3.5MM CANNULATED SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A 1.25MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668036 1.25MM THREADED GUIDE WIRE 150MM WIRE, SURGICAL LRN OBERDORF SYNTHES PRODUKTIONS GMBH 4L16743 07611819733121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: 3.5 MM CANNULATED| UNK - SCREWS: 3.5 MM CANNULATED