BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET

    MDR report key: 10308457 · Received July 22, 2020

    Report

    Report Number
    8030965-2020-05119
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Report Date
    July 3, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTD
    UDI-DI
    07611819220966
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY LOT: PART: 399.092. LOT: 5945482. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 28.MAY.2018. 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 LOCK DEVICE WAS BROKEN AND UNABLE TO HOLD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773659 REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET FORCEPS HTD OBERDORF SYNTHES PRODUKTIONS GMBH 5945482 07611819220966

    Patients

    Seq Age Sex Outcome Treatment
    1