BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE SOLO

    MDR report key: 3132020 · Received April 30, 2013

    Report

    Report Number
    1213643-2013-00183
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 5, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FQH
    PMA / PMN Number
    K942886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSED FOR THE REPORTED EVENT. THE SUBJECT PRODUCT IS IN THE PROCESS OF BEING RETURNED FOR EVALUATION. THEREFORE, NO CONCLUSION CAN BE DRAWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. SEE MDR 1213643-2013-00184 FOR INFORMATION RELATED TO THE SIMPULSE DEVICE USED IN THE INITIAL PROCEDURE.

    Description of Event or Problem · 1

    INFORMATION AS REPORTED TO DAVOL: THE PATIENT HAD A SURGICAL HIP PROCEDURE DURING WHICH THE SURGEON USED A SIMPULSE SOLO DEVICE. DUE TO A POST OP REACTION, A REVISION PROCEDURE WAS PERFORMED EIGHT MONTHS AFTER SURGERY. DURING THE CASE, THE SURGEON FOUND A PIECE OF THE DISTAL TIP OF THE SIMPULSE SOLO DEVICE THAT HAD BEEN USED IN THE INITIAL SURGERY (SEE MDR 1213643-2013-00184). DURING THE REVISION PROCEDURE, A SIMPULSE SOLO DEVICE WAS USED, AND A PIECE OF THAT TIP ALSO BROKE. THE FRAGMENTS WERE REMOVED FROM THE SIDE WITHOUT ISSUE AND THERE WAS NO PATIENT INJURY. IF THE PIECE HAD NOT BEEN REMOVED IT COULD HAVE RESULTED IN THE NEED FOR SURGICAL INTERVENTION AND AS SUCH AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188976 SIMPULSE SOLO FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUVKF140

    Patients

    Seq Age Sex Outcome Treatment
    1