BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 48MM

    MDR report key: 8561340 · Received April 29, 2019

    Report

    Report Number
    8030965-2019-63241
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 1, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819268890
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 413.348S, LOT: L147640, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 06.OCTOBER 2016, EXPIRY DATE: 01.SEPTEMBER 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS CONDUCTED. THE COMPLAINT CONDITION THE SCREW HAS LOOSENED AND WAS DISPLACED CAN BE CONFIRMED ACCORDING TO THE RECEIVED PICTURES. THEREFORE THIS COMPLAINT WILL BE RATED AS CONFIRMED. THE INVESTIGATION AT THE CORRESPONDING MANUFACTURING SITE SHOWS THAT THERE IS NO DEVIATION OR FAULT AT THE SCREWS, THUS THE MANUFACTURING EVALUATION ITSELF IS RATED AS UNCONFIRMED. IN THIS REGARD, FOR THE PICTURE INVESTIGATION RESULT, THE ANALYSIS CODE "LOOSE" HAS BEEN CHOSEN, AND FOR THE MANUFACTURING RESULT THE ANALYSES CODE "NO DEFECT FOUND". SUMMARY OF THE MANUFACTURING EVALUATION: THE RECEIVED CONDITION OF THE ARTICLE DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION ¿THE UNKNOWN LOCKING SCREW WAS NOTICED TO HAVE LOOSENED AND WAS DISPLACED, SINCE ALL THE RELEVANT FEATURES RELATED TO THE SCREW WERE MEASURED DURING THIS INVESTIGATION AND HAVE FULFILLED ITS SPECIFICATION ACCORDING TO THE DRAWING AND NO DEVIATIONS WERE FOUND IN THE DOCUMENTATION. THUS, THIS COMPLAINT IS RATED AS NOT CONFIRMED AND NOT VALID. SINCE NO MANUFACTURING DEFICIENCY HAS BEEN IDENTIFIED, NO FURTHER ACTIONS HAVE BEEN TAKEN. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. THERAPY DATE IS (B)(6) 2019. 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

    DATE OF EVENT: UNKNOWN DATE IN 2019. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN DATE 2019. 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 ON (B)(6) 2019, THE UNKNOWN LOCKING SCREW WAS NOTICED TO HAVE LOOSENED AND WAS DISPLACED. ON (B)(6) 2019, DISTAL FEMORAL OSTEOTOMY WAS ORIGINALLY PERFORMED WITH TOMOFIX MEDIAL DISTAL FEMUR AND THE LOCKING SCREW. THE UNKNOWN LOCKING SCREW WAS INSERTED WITH A TORQUE LIMITATION INSTRUMENT IN THE SURGERY. THE DOCTOR REMOVED THE IMPLANT. CHANGED THE POSITION A LITTLE, AND USED THE SAME PRODUCT MDF. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE LIMITATION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), TOMOFIX PLATE (PART# 04.120550S, LOT# 1L87207, QUANTITY 1), LOCKING SCREW ((PART# 413.346S , LOT# 9797774 , QUANTITY: 1); LOCKING SCREW (PART# 413.355S, LOT# L823517, QUANTITY: 1); LOCKING SCREW (PART# 413.365S, LOT# 1L64873, QUANTITY: 1); LOCKING SCREW (PART# 413.370S, LOT# L612536, QUANTITY: 1); LOCKING SCREW (PART# 413.370S, LOT# L810248, QUANTITY: 1); LOCKING SCREW (PART# 413.370S, LOT# 1L64874, QUANTITY: 1); LOCKING SCREW (PART# 413.375S, LOT# L838090, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 48MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355298 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 48MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L147640 07611819268890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention