BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE

    MDR report key: 8935593 · Received August 27, 2019

    Report

    Report Number
    8030965-2019-67760
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 29, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819152359
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6- DEVICE HISTORY LOT: PART: 412.214S, LOT: 1L48769, MANUFACTURING SITE: SELZACH, SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG, RELEASE TO WAREHOUSE DATE: 14. SEP. 2018, EXPIRY DATE: 01. SEP. 2028. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT L996167 IN MEZZOVICO AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 412.214 WITH LOT L996167 WERE REVIEWED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL DATA-D4. 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 IS AN UNKNOWN DATE IN 2019. 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. (B)(4). 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 (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR HIP FRACTURE WITH THE FEMORAL NECK SYSTEM (FNS). AFTER THE SURGERY, THE PATIENT STARTED FULL WEIGHT-BEARING, BUT THE HOSPITAL CONFIRMED THE RETROFLEXION OF THE FEMUR. THE PATIENT WILL UNDERGO REVISION SURGERY TO REPLACE THE FEMORAL HEAD. THE SURGEON COMMENTED THAT THE FIXATION BECAME WEAK BECAUSE THE FRACTURE TYPE WAS UNSTABLE. IN ADDITION, THE SURGEON COMMENTED THAT THE EVENT WAS CAUSED BY THE POOR ADAPTATION AND REDUCTION. THIS REPORT IS FOR A 5.0 MM TITANIUM (TI) LOCKING SCREW. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729986 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 1L48769 07611819152359

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention