BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE 1.1MM X 15?

    MDR report key: 4243479 · Received November 11, 2014

    Report

    Report Number
    1221934-2014-00487
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED AND THEREFORE NOT AVAILABLE FOR AN EVALUATION. A DEFINITE ROOT CAUSE FOR THIS FAILURE CANNOT BE DETERMINED. FROM HISTORICAL INVESTIGATIONS, BEND IN GUIDE WIRE HAVE BEEN TYPICALLY ASSOCIATED WITH OFF AXIS INSERTION, LEVERING DURING INSERTION. IT WAS NOTED THAT THE PATIENT HAD A HARD BONE QUALITY AND THE SURGICAL TECHNIQUE MAY HAVE CONTRIBUTED TO THE FAILURE. A BATCH REVIEW WAS CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE COMPLAINT HISTORY OF THESE FAILURES, AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING AN ACL TWO OF THE CUSTOMER'S MILAGRO ADVANCE 8 X 23MM SCREWS CRACKED UPON INSERTION. THE SALES REP REPORTED THAT THE SURGEON DRILLED THE TUNNEL, PASSED THE NITINOL GUIDEWIRE 1.1MM X 38CM INTO THE TUNNEL THEN TAPPED AND INSERTED THE 1ST MILAGRO SCREW BUT THE SCREW WOULD NOT ADVANCE AND THEN CRACKED. THE SURGEON FULLY REMOVED THIS SCREW AND UPON REMOVING THE GUIDEWIRE NOTICED IT WAS BENT AND HAD CAUGHT ON THE SCREW NO ALLOWING IT TO ADVANCE. THE SURGEON REPEATED THESE STEPS AND AGAIN CRACKED THE SCREW AND BENT THE GUIDEWIRE. THE SURGEON COMPLETED THE PROCEDURE WITH A 3RD SAME TYPE, SAME SIZE SCREW IN THE SAME BONEHOLE BUT BLEW OUT THE BACK OF THE FEMUR WALL. THE SURGEON THEN USED ANOTHER MILAGRO ADVANCE 8 X 23MM SCREW ON THE LATERAL MEDIAL SIDE TO SECURE THE FIXATION BUT ON THE 1ST ATTEMPT AND 2ND ATTEMPT BENT TWO MORE GUIDEWIRES BUT DID NOT CRACK ANY MORE SCREWS, THE SURGEON COMPLETED THIS 2ND FIXATION WITH THE SAME INITIAL SCREW AND A 3RD GUIDEWIRE WITH NO PATIENT CONSEQUENCES. THE SALES REP REPORTED THAT THE PROCEDURE WAS DELAYED FOR 28 MINUTES. THE SALES REP REPORTED THAT THE SURGEON HAD TOO MUCH EXTENSION AND DID NOT FLEX THE KNEE ENOUGH. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICES. ADDITIONAL INFORMATION RECEIVED BY MITEK COMPLAINTS ON (B)(6) 2014: THE SALES REP REPORTED THAT THE PATIENT WAS A (B)(6) YEAR OLD MALE, WITH HARD BONE QUALITY AND THAT THE SURGEON USED A 10MM DRILL SIZE. THE SALES REP STATED THAT THE SURGEON BROUGHT IN A C-ARM TO MAKE SURE ALL THE SCREWS WERE ACCOUNTED FOR AND NOTHING WAS LEFT NEXT TO THE POPLITEAL ARTERY. THE SALES REP REPORTED THAT THE MEDIAL LATERAL 2ND IMPLANT PLACEMENT WAS TO SECURE THE FIXATION DUE TO THE SURGEON BLOWING OUT THE FEMUR WALL AND THAT SECOND IMPLANT WOULD NOT HAVE BEEN NEEDED OTHERWISE. SEE ASSOCIATED MED WATCH 1221934-2014-00484, 1221934-2014-00485, 1221934-2014-00486, 1221934-2014-00488, 1221934-2014-00489

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727558 GUIDEWIRE 1.1MM X 15? MITEK ACL ACCESSORIES FZX DEPUY MITEK NA 3734609

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R