BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM TI END CAP T40 STARDRIVE 15MM EXT-STER/FEMORAL NAILS-EX

    MDR report key: 8441393 · Received March 21, 2019

    Report

    Report Number
    8030965-2019-62147
    Event Type
    Injury
    Date Received
    March 21, 2019
    Report Date
    February 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819777422
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DATE OF REVISION SURGERY IS UNKNOWN. CORRECTED EVENT DESCRIPTION. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS INITIALLY IMPLANTED WITH EXPERT END CAP FOR ANTEGRADE FEMORAL NAIL (AFN) AND R/AFN, EXPERT RFN NAIL. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE RETROGRADE/ANTEGRADE FEMORAL NAIL (R/AFN) END CAP FROM AN EXPERT RETROGRADE FEMORAL NAIL (RFN) AS IT HAD COMPLETELY BACKED OUT. THE EXPERT RFN NAIL REMAINS IN-SITU AND THE END CAP WAS SUCCESSFULLY REMOVED. NO NEW END CAP WAS IMPLANTED. THE NAIL WAS UNAFFECTED AND REMOVAL WAS DEEMED UNNECESSARY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY AND ADVERSE EVENT TO THE PATIENT REPORTED. CONCOMITANT DEVICE: EXPERT RETROGRADE FEMORAL NAIL (PART: 04.013.632S, LOT: UNKNOWN, QUANTITY: 1) . RFN SPIRAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) . SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) END CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRO CODE: HWC. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 (B)(6) 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 (B)(6) 2018, THE PATIENT WAS INITIALLY IMPLANTED WITH EXPERT END CAP FOR ANTEGRADE FEMORAL NAIL (AFN) AND R/AFN, EXPERT RFN NAIL. ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE RETROGRADE/ANTEGRADE FEMORAL NAIL (R/AFN) END CAP FROM AN EXPERT RETROGRADE FEMORAL NAIL (RFN) AS IT HAD COMPLETELY BACKED OUT. THE EXPERT RFN NAIL REMAINS IN-SITU AND THE END CAP WAS SUCCESSFULLY REMOVED. NO NEW END CAP WAS IMPLANTED. THE NAIL WAS UNAFFECTED AND REMOVAL WAS DEEMED UNNECESSARY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY AND ADVERSE EVENT TO THE PATIENT REPORTED. CONCOMITANT DEVICE: EXPERT RETROGRADE FEMORAL NAIL (PART: 04.013.632S, LOT: UNKNOWN, QUANTITY: 1); RFN SPIRAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1).  THIS REPORT IS FOR ONE (1) END CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233382 12MM TI END CAP T40 STARDRIVE 15MM EXT-STER/FEMORAL NAILS-EX ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 07611819777422

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention