BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC

    MDR report key: 9157643 · Received October 4, 2019

    Report

    Report Number
    8030965-2019-69040
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Report Date
    September 16, 2019
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    OVE
    UDI-DI
    07611819969742
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE COMPLAINT CONDITION THAT THE SCREWDRIVER TIP IS STRIPPED, CAN BE CONFIRMED ACCORDING TO THE RECEIVED PICTURES. PRODUCT WAS NOT RETURNED BUT IMAGES OF THE AFFECTED DEVICE WERE SHARED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: 03.617.902, LOT: L912148, MANUFACTURING SITE: HÄGENDORF , RELEASE TO WAREHOUSE DATE: 11 JULY 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.

    Additional Manufacturer Narrative · 1

    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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE ANGLED AWL IN ZEROP WAS BENT AND TWO (2) T8 STARDRIVES WERE WORN AND STRIPPED, THE SCREWS KEPT FALLING OFF OF THE SCREWDRIVERS. THIS WAS OBSERVED PRIOR TO OPERATING ON A PATIENT. CONCOMITANT DEVICE: UNK - SCREWS: TRAUMA (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC. THIS IS REPORT 1OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951034 STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE OBERDORF : SYNTHES PRODUKTIONS GMBH L912148 07611819969742

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: TRAUMA