BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUC-FORC W/POINT SOFTLO L155

    MDR report key: 8434099 · Received March 19, 2019

    Report

    Report Number
    8030965-2019-62086
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 18, 2019
    Report Date
    February 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTD
    UDI-DI
    07611819220935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. DEVICE HISTORY LOT: PART: 399.086. LOT: 5943906. MANUFACTURING SITE: SALZBURG. RELEASE TO WAREHOUSE DATE: 08.FEB.2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. 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

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE HISTORY LOT: PART: 399.086; LOT: 5943906; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: 08.FEB.2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE 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, AN OPEN INTERNAL FIXATION (ORIF) SURGERY FOR THE PILON FRACTURE ON THE FIBULA WAS PERFORMED. AS SOON AS THE SURGEON HELD THE BONE WITH THE REDUCTION FORCEPS WHICH WAS IN QUESTION, THE TIP OF THE SAID FORCEPS WAS BROKEN OFF. THERE WERE NO BROKEN PIECES OF THE DEVICE REMAINED IN THE PATIENT'S BODY REPORTED. IT WAS THE FIRST TIME THE FORCEPS WAS USED SINCE IT HAS BEEN PURCHASED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY, ALTHOUGH, THERE WAS NO REPORT OF HOW THE SURGERY WAS FINISHED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226128 REDUC-FORC W/POINT SOFTLO L155 FORCEPS HTD OBERDORF SYNTHES PRODUKTIONS GMBH 5943906 07611819220935

    Patients

    Seq Age Sex Outcome Treatment
    1