BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL INTRODUCER

    MDR report key: 8150783 · Received December 11, 2018

    Report

    Report Number
    1818910-2018-77742
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 18, 2018
    Report Date
    November 13, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWA
    UDI-DI
    10603295130215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DHE6P UPYA TSIYENNTTH ECSO DIES: SNUOB MCIOTDTEI NAGV ATIHLIASB LREE P(O3R1T9 1P)U RUSSUEADN TT OT OC ATPHTEU RPER OTVHIES ISOUNRSG IOCFA L2 1I NCTFERR,V EPNATRITO N803D>E PTUHYI SS YRNETPHOERST IMSA YS UBBEM IBTATSIENDG OTNH IISN FROERPMOARTTI OPNU RWSHUIACNHT DTEOP UTYH ES YPNRTOHVEISS IHOANSS NOOFT 2B1E ECNF RA,B LPEA RTTO 8I0N3V. E STTHIIGSA TREE POORR TV EMRAIYF YB EP RBIAOSRE DT OO NT HIEN FROERQMUAITRIEODN RWEHPIOCRHT IDNEGP UDYA TSEY. N TTHHEISS HRAESP ONROTT DBOEEESN NAOBTL ER ETFOL EICNTV EAS TCIOGNACTLEU SOIRO NV EBRYI FFYD AP,R IDOERP UTYO STYHNET HREESQ UOIRR EIDT SR EEPMOPRLTOIYNEGE SD ATTHEA.T TTHHIES RREEPPOORRTT CDOONESST INTOUTT ERSE FALNE CATD MAI SCSOINOCNL UTSHIAOTN TBHYE FDDEAV,I CDEE,P UDYE PSUYYN TSHYENST HOERS, I TOSR EIMTPSL OEYMEPELSO YTEHEAST CTAHUES ERDE POORR TC OCNOTNRSITBIUTTUETDE ST OA NT HAED MPIOSTSEINOTNI ATLH AETV ETNHTE DDEESVCIRCIEB,E DD EIPNU YT HSIYSN TRHEEPSO, R TO. RIITFS IENMFPOLROMYAETEISO NC AIUSS EODB TOARI NCEODN TTRHIABTU TWEADS TNOO TT HAEV APIOLTAEBNLTEI AFLO RE VTEHNET IDNEISTCIRAILB EMDE DIWNA TTCHHI, S AR EFPOOLRLTO. W-UIPF MIENDFWOARTMCAHT IWOINL LI SB EO BFTIALIENDE DA ST HAAPTP RWOAPSR INAOTTE. AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 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

    PRODUCT COMPLAINT # (B)(4). PLEASE NOTE, THE DATE RECEIVED BY MANUFACTURER WAS DOCUMENTED INCORRECTLY ON MWR-(B)(4). THE CORRECT DATE RECEIVED BY MANUFACTURER FOR THE FOLLOW-UP INFORMATION ON MWR-(B)(4) IS 12/12/18.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONSISTENT FRACTURING OF THE FINE TUNING DIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992208 ATTUNE FEMORAL INTRODUCER ATTUNE INSTRUMENTS : INSERTION DEVICES HWA DEPUY IRELAND - 9616671 B0211 10603295130215

    Patients

    Seq Age Sex Outcome Treatment
    1