BEUDAMED
    FDA Adverse Event Death Summary report: N

    TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/LONG-STERILE

    MDR report key: 10546646 · Received September 17, 2020

    Report

    Report Number
    1833824-2020-00065
    Event Type
    Death
    Date Received
    September 17, 2020
    Report Date
    August 27, 2020
    Manufacturer
    RTI SURGICAL
    Product Code
    JDQ
    UDI-DI
    07611819757592
    PMA / PMN Number
    K001709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 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. INVESTIGATION SUMMARY: 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. DEVICE HISTORY LOT: STERILE PART:. PART: 498.807S. LOT: L066771. MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 19.JUL.2016. EXPIRY DATE: 01.JUL.2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART: PART # 498.807. SYNTHES LOT # P230950. SUPPLIER LOT # P230950. LOT EXPIRATION DATE: 30 NOV 2020. RELEASE TO WAREHOUSE DATE: 02 AUG 2016. SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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, PATIENT UNDERWENT A THR REVISION + GT ORIF FOR A VANCOUVER B3 FRACTURE. PATIENT WAS IMPLANTED WITH A TROCH REATHACHAM DEVICE LARGE, F/CABLE SYSTEM. AFTER 4 MONTHS FOLLOW UP, FRACTURE WAS REVISED. PATIENT PASSED AWAY SECONDARY TO INFECTION. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/LONG-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010684 TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/LONG-STERILE CERCLAGE FIXATION JDQ RTI SURGICAL L066771 07611819757592

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death CERCL-CABLE W/CRIMP 1.7| CERCL-CABLE W/CRIMP 1.7| CERCL-CABLE W/CRIMP 1.7| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| CERCL-CABLE W/CRIMP 1.7| CERCL-CABLE W/CRIMP 1.7| CERCL-CABLE W/CRIMP 1.7| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4