BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE

    MDR report key: 3943357 · Received July 18, 2014

    Report

    Report Number
    2520274-2014-12282
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ROY, S., LIM, C., & TAN, K. (2014) A USEFUL SURGICAL TECHNIQUE FOR RETRIEVAL OF A BROKEN GUIDE PIN IN THE MIDFOOT. THE JOURNAL OF FOOT & ANKLE SURGERY 53, 120-123. THIS REPORT IS FOR AN UNKNOWN GUIDE PIN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: A USEFUL SURGICAL TECHNIQUE FOR RETRIEVAL OF A BROKEN GUIDE PIN IN THE MIDFOOT. ROY, S., LIM, C., & TAN, K. (2014) A USEFUL SURGICAL TECHNIQUE FOR RETRIEVAL OF A BROKEN GUIDE PIN IN THE MIDFOOT. THE JOURNAL OF FOOT & ANKLE SURGERY 53, 120-123. THIS WAS A RETROSPECTIVE STUDY ON RETRIEVAL TECHNIQUES FOR BROKEN INSTRUMENTS AND/OR IMPLANTS IN ORTHOPEDIC PROCEDURES. THIS PARTICULAR CASE INVOLVED A (B)(6) WOMAN WHO HAD UNDERGONE INTERNAL FIXATION WITH 3.5 MM CANNULATED SCREWS AND GUIDE PIN FOR A LISFRANC JOINT COMPLEX INJURY OF HER RIGHT FOOT. THE ORIGINAL SURGERY WAS PERFORMED ON AN EMERGENCY BASIS. DURING THE INITIAL PROCEDURE, THE 1.25 MM GUIDE PIN BROKE AS THE SURGEON WAS DRILLING THROUGH THE BASE OF THE SECOND METATARSAL INTO THE INTERMEDIATE CUNEIFORM. THE GUIDE PIN FRAGMENT WAS EMBEDDED IN THE INTERMEDIATE CUNEIFORM WITH THE SHARP, THREADED END HAVING PASSED THROUGH THE NAVICULOCUNEIFORM JOINT TO LODGE IN THE NAVICULAR. THE PATIENT WAS REFERRED TO A CLINIC TWO WEEKS LATER FOR EXAMINATION OF THE BROKEN GUIDE PIN. A SURGERY WAS SCHEDULED FOR SIX WEEKS POSTOPERATIVELY, IN ORDER TO REMOVE THE GUIDE PIN AS WELL AS THE CANNULATED SCREWS. THIS WAS CONSIDERED TO BE THE EARLIEST REASONABLE TIME FOR REMOVAL WITHOUT COMPROMISING BONE HEALING. A MINIMALLY INVASIVE APPROACH FOR REMOVAL OF THE FRAGMENT WAS SELECTED IN ORDER TO MINIMIZE DAMAGE TO THE JOINT AND ADJACENT OSSEOUS AND SOFT TISSUE STRUCTURES. THE THREE FIXATION SCREWS WERE TAKEN OUT FIRST AND THE GUIDE PIN WAS DISLODGED AND REMOVED VIA THE DRILL BIT. THE STABILITY OF THE LISFRANC JOINT WAS CONFIRMED BY X-RAY EVALUATION; THE INTEGRITY OF THE GUIDE PIN FRAGMENT WAS ALSO CONFIRMED. THE PATIENT WAS NOTED TO THEN HAVE EXPERIENCED AN UNREMARKABLE POSTOPERATIVE COURSE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN GUIDE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422751 GUIDE FZX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention