BEUDAMED
    FDA Adverse Event Death Summary report: N

    1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE

    MDR report key: 10546876 · Received September 17, 2020

    Report

    Report Number
    1833824-2020-00068
    Event Type
    Death
    Date Received
    September 17, 2020
    Report Date
    August 27, 2020
    Manufacturer
    RTI SURGICAL
    Product Code
    JDQ
    UDI-DI
    07611819757615
    PMA / PMN Number
    K992616
    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. H10 ADDITIONAL NARRATIVE: H4, H6: PART: 611.105.01S. LOT: L128405. MANUFACTURING SITE: SELZACH. SUPPLIER: FRÜH AG. RELEASE TO WAREHOUSE DATE: SEPTEMBER 12, 2016. EXPIRY DATE: SEPTEMBER 01, 2026. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY, DEVICE HISTORY RECORD (DHR) REVIEW IS DONE FOR NON-STERILE PART: PART: 611.105.01. LOT: P251812. MANUFACTURING SITE: MONUMENT. RELEASE TO WAREHOUSE DATE: AUGUST 23, 2016. MANUFACTURING LOCATION: SUPPLIER-RTI SURGICAL / INSPECTION AND RELEASE BY: MONUMENT. PART: 611.105.01, 1.7MM COCR CABLE WITH TI CRIMP 750MM. LOT: P251812 (NON-STERILE). RELEASE TO WAREHOUSE DATE: AUGUST 17, 2016. PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF CONFORMANCE RECEIVED FROM RTI SURGICAL WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING LABEL LOG WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. 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 HISTORY LOT: 02-SEP-2020 BY: (B)(6). A DHR REVIEW COULD NOT BE PERFORMED FOR THIS PI. THIS IS THE EUROPEAN LOT NUMBER. PLEASE PROVIDE THE CORRESPONDING MONUMENT LOT NUMBER AND RESUBMIT. DEVICE HISTORY REVIEW: 02-SEP-2020 BY: (B)(6). A DHR REVIEW COULD NOT BE PERFORMED FOR THIS PI. THIS IS THE EUROPEAN LOT NUMBER. PLEASE PROVIDE THE CORRESPONDING MONUMENT LOT NUMBER AND RESUBMIT. 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) 1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012843 1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ RTI SURGICAL L128405 07611819757615

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death CERCL-CABLE W/CRIMP Ø1.7| CERCL-CABLE W/CRIMP Ø1.7| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| TRD TROCHANTER REATTACHM-DEVICE LRG F/CA| CERCL-CABLE W/CRIMP Ø1.7| CERCL-CABLE W/CRIMP Ø1.7| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| TRD TROCHANTER REATTACHM-DEVICE LRG F/CA