BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.25MM THREADED GUIDE WIRE 150MM

    MDR report key: 6051791 · Received October 24, 2016

    Report

    Report Number
    3000270450-2016-10249
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    LRN
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODE IS HTY. (B)(4). THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. (B)(6). DEVICE HISTORY RECORD REVIEWS WERE PERFORMED FOR THE SUBJECT DEVICE LOT. NON-STERILE PART # 292.620/ LOT # 9829627, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 8TH FEBRUARY 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILE PART # 292.620, LOT # 9840874, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 24TH FEBRUARY 2016, EXPIRY DATE: 1ST FEBRUARY 2026. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 1.25MM THREADED GUIDE WIRE 150MM BROKE DURING A DISTAL FRACTURE PROCEDURE OF THE TIBIA AND FIBULA ON (B)(6) 2016. A DISTAL FIBULA PLATE AND A LOCKING COMPRESSION PLATE (LCP) CLOVER PLATE WERE USED. IN ORDER TO FIX THE REAR BONE PIECES WITH A 4.0MM CANNULATED SCREW SYSTEM (CSS), THE SURGEON INSERTED A GUIDE WIRE FROM THE DISTAL FRONTAL TIBIA. DUE TO THE IMPROPER POSITIONING, SURGEON TURNED THE DRILL COUNTERCLOCKWISE TO REMOVE THE GUIDE WIRE. THIS RESULTED IN THE GUIDE WIRE CUTTING OFF FROM THE SCREW AREA. SURGEON MADE A SMALL SKIN INCISION AND DECIDED NOT TO TAKE THE BROKEN PART OUT OF THE PATIENT. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED AND IF A NEW GUIDE WIRE WAS USED TO PROCEED. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY REPORTED. THERE IS NO PLAN TO REOPERATE. CONCOMITANT DEVICES REPORTED: DISTAL FIBULA PLATE (PART# UNKNOWN, LOT # UNKNOWN, QTY 1), LCP CLOVER PLATE (PART # UNKNOWN, LOT # UNKNOWN, QTY 1), 4.0MM CCS (PART# UNKNOWN, LOT # UNKNOWN, QTY 1). THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703565 1.25MM THREADED GUIDE WIRE 150MM WIRE, SURGICAL LRN SYNTHES SELZACH 9840874

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4.0MM CCS| DISTAL FIBULA PLATE| LCP CLOVER PLATE