BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER

    MDR report key: 8569523 · Received May 1, 2019

    Report

    Report Number
    8030965-2019-63335
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819789821
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 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. 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. PART: 04.005.528S. LOT: L832369. MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 04.APRIL 2018. EXPIRY DATE: 1.MARCH 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE 04.05.528 / L798628 WAS MANUFACTURED IN MEZZOVICO. PART: 04.005.528. LOT: L798628. MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: 27.FEBRUARY 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN DATE IN 2019. DEVICE EVALUATED BY MFR: 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 THE PATIENT UNDERWENT A DEBRIDEMENT AND HARDWARE REMOVAL SURGERY ON (B)(6) 2019. THE PATIENT WAS INITIALLY WITH THE EXPERT TIBIAL NAIL SYSTEM ON (B)(6) 2019, DUE TO A FIBULA DIAPHYSEAL FRACTURE. ON (B)(6) 2019, THE PATIENT VISITED THE HOSPITAL AND POST-OPERATIVE COURSE WAS GOOD. ON (B)(6) 2019, THE PATIENT VISITED THE HOSPITAL AGAIN AND REPORTED SWELLING OF THE AFFECTED AREA AND WAS SUSPECTED OF INFECTION. THE HOSPITAL PLANNED TO REMOVE ONE LOOSENED SCREW IN THE DEBRIDEMENT SURGERY. DURING THE DEBRIDEMENT SURGERY, THE OTHER SCREWS LOST THEIR FIXATION AND THE INFECTION SPREAD THROUGH THE IMPLANTS FROM THE LESION. THE SURGEON REMOVED ALL ETN IMPLANTS AND APPLIED A VACUUM-ASSISTED CLOSURE THERAPY. THE PATIENT IS UNDER FOLLOW-UP AND WILL BE APPLIED EXTERNAL FIXATION AFTER THE AFFECTED AREA BECOMES STABLE. THERE IS A POSSIBILITY OF LOWER LIMB AMPUTATION DUE TO GANGRENOUS FIVE FINGERS. THE SURGEON REPORTED THAT AFTER (B)(6) 2019, THE PATIENT DEVELOPED PURULENT MENINGITIS FROM AN UNKNOWN CAUSE AND THERE WAS NO PROBLEM WITH THE DEVICES. THERE WAS A SURGICAL DELAY OF NINETY (90) MINUTES. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER. THIS IS REPORT 5 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364895 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L832369 07611819789821

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention