BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM

    MDR report key: 8791492 · Received July 15, 2019

    Report

    Report Number
    8030965-2019-66251
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 18, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819268807
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 413.330S, LOT: 9820786, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 18.FEBRUARY 2016, EXPIRY DATE: 01.FEBRUARY 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: PRODUCT WAS NOT RETURNED. 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 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

    CONCOMITANT DEVICE REPORTED: TOMOFIX TIBIAL HEAD PLATE (PART# 440.837S, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); HANDLE LARGE WITH QUICK COUPLING (PART# 03.010.516, LOT# T156533, QUANTITY# 1).

    Additional Manufacturer Narrative · 1

    PART RETURNED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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, THE PATIENT UNDERWENT REMOVAL OF TOMOFIX DUE TO BONE HEALING. DURING THE PROCEDURE, SINCE IT WAS DIFFICULT TO USE THE HANDLE OF ONE (1) LARGE HANDLE WITH QUICK COUPLING, ANOTHER ONE (1) HANDLE LARGE WITH QUICK COUPLING WAS USED. THE OPERATION PROCEEDED SMOOTHLY USING THE HANDLE LARGE WITH QUICK COUPLING. HOWEVER, WHEN THE SURGEON TRIED TO REMOVE THE LAST LOCKING SCREW THAT WAS AT THE MOST DISTAL POINT OF THE PLATE, THE HANDLE LARGE WITH QUICK COUPLING STRIPPED THE LOCKING SCREW HEAD. THE SURGEON THEN TRIED TO REMOVE THE LOCKING SCREW USING ONE (1) CONICAL EXTRACTION SCREW. HOWEVER, THE CONICAL EXTRACTION SCREW BROKE, AND THE BROKEN PIECE REMAINED IN THE LOCKING SCREW HEAD. DUE TO THIS SITUATION, A CARBIDE DRILL COULD NOT BE USED. FINALLY, THE SURGEON EXTENDED THE SURGICAL INCISION LARGELY (ORIGINALLY, THE INCISION SIZE WAS SHORT.). THEN, THE SURGEON COULD REMOVE THE SCREW SOMEHOW BY ROTATING THE PLATE. THERE WAS A FORTY-FIVE (45) MINUTES OF SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: TOMOFIX TIBIAL HEAD PLATE (PART# 440.837S, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); HANDLE LARGE WITH QUICK COUPLING (PART# 03.010.516, LOT# UNKNOWN, QUANTITY# 1) . THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582883 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9820786 07611819268807

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention