BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE Ø1.25 THREAD-TIP L150/5 SST

    MDR report key: 6904262 · Received September 29, 2017

    Report

    Report Number
    3000270450-2017-10343
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 10, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    LRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. HOSPITAL TELEPHONE: (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER L030664. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 22. JUNE 2016. EXPIRATION DATE: 01. JUNE 2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OR STERILIZATION OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCE WERE GENERATED DURING THE PRODUCTION OR STERILIZATION OF THE SUBJECT DEVICE. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT L015245 IN BALSTHAL AND REPACKED/STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 292.663.10 (PACKAGE OF 10 PIECES) WITH LOT L015245 WERE REVIEWED: NO NCRS WERE GENERATED DURING PRODUCTION OF THE UNSTERILE PART 292.663.10 WITH LOT L015245. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON MARCH 10, 2017 THE KIRSCHNER WIRE (K-WIRE) BROKE WHILE BEING INSERTED INTO THE DISTAL TIBIA. THE SURGEON WAS UNABLE TO REMOVE THE K-WIRE. NO SURGICAL DELAY IS REPORTED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS REPORT IS FOR ONE (1) STAINLESS STEEL KIRSCHNER WIRE WITH TREADED TIP THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A DELAY BUT IT IS UNKNOWN HOW LONG. THEY WOULD HAVE BEEN USING X-RAY GUIDANCE FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684219 K-WIRE Ø1.25 THREAD-TIP L150/5 SST WIRE, SURGICAL LRN SYNTHES SELZACH L030664

    Patients

    Seq Age Sex Outcome Treatment
    1