BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUC-FORC W/POINT SOFTLO L155

    MDR report key: 10870014 · Received November 19, 2020

    Report

    Report Number
    8030965-2020-09079
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Report Date
    October 26, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    UDI-DI
    07611819220935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. 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 HISTORY LOT PART NUMBER: 399.086; LOT NUMBER: 5931752; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: JAN 20, 2015. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FORCEPS WERE FOUND TO HAVE A BROKEN TIP. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) REDUC-FORC W/POINT SOFTLO L155. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335909 REDUC-FORC W/POINT SOFTLO L155 FORCEPS HTD SYNTHES GMBH 5931752 07611819220935

    Patients

    Seq Age Sex Outcome Treatment
    1