BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAIL-STER

    MDR report key: 8264699 · Received January 21, 2019

    Report

    Report Number
    8030965-2019-60121
    Event Type
    Injury
    Date Received
    January 21, 2019
    Report Date
    December 28, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819789845
    PMA / PMN Number
    K172157
    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. DEVICE HISTORY LOT PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART NO.: 04.005.534S, LOT NO.: L133622, MANUFACTURING LOCATION: SELZACH, SUPPLIER: IL-MEDTEC AG, RELEASE TO WAREHOUSE DATE: 31.AUG.2016, EXPIRY DATE: 01.AUG.2026. NON-STERILE 04.005.534 / L096481 WAS MANUFACTURED IN MEZZOVICO. RELEASE TO WAREHOUSE DATE: 17.AUG.2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A NAIL (NOT DEPUY SYNTHES PRODUCT) WAS APPLIED TO SURGERY FOR FEMORAL SUBTROCHANTERIC FRACTURES. PSEUDARTHROSIS OCCURRED AND THE NAIL (NOT DEPUY SYNTHES PRODUCT) WAS ALSO BROKEN AFTER THE SURGERY. ON (B)(6) 2017, REOPERATION WAS PERFORMED AND THE NAIL (NOT DEPUY SYNTHES PRODUCT) WAS REMOVED. A TFNA FEMORAL NAIL IN QUESTION, LOCKING SCREW, UNKNOWN LOCKING COMPRESSION PLATE, UNKNOWN CABLE AND A PIECE OF THE PATIENT¿S ILIUM WERE IMPLANTED DURING THE SURGERY. ON (B)(6) 2018, THE TROCHANTERIC FIXATION ADVANCE (TFNA) FEMORAL NAIL AND LOCKING SCREW WERE OBSERVED TO HAVE BEEN BROKEN. ON (B)(6) 2018, ANOTHER RE-OPERATION WAS PERFORMED. THE TFNA IMPLANTS WERE REMOVED AND BIPOLAR HIP ARTHROPLASTY WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY. THE PATIENT IS CURRENTLY IN THE HOSPITAL. CONCOMITANT DEVICES REPORTED: LOCKING COMPRESSION PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1), CABLE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57762 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAIL-STER SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L113622 07611819789845

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE EVENT DESCRIPTION