BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM GUIDE WIRE 400MM

    MDR report key: 6394648 · Received March 10, 2017

    Report

    Report Number
    2520274-2017-10803
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 15, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRAMEDULLARY NAILING PROCEDURE OF THE FEMUR ON (B)(6) 2017. THE SURGEON HAD INSERTED THE 9 MM LATERAL ENTRY RECON NAIL AND WAS INSERTING THE 6.5 MM RECON SCREWS INTO THE FEMORAL HEAD, BUT THE WIRES KEEP GOING POSTERIOR IN THE FEMORAL HEAD. THE SURGEON REPOSITIONED THE AIMING ARM; HOWEVER THE WIRE CONTINUED TO GO POSTERIOR. THE SURGEON WAS ABLE TO PLACE THE WIRE IN THE CENTER OF THE FEMORAL HEAD AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE SURGICAL DELAY DUE TO THE REPOSITIONING OF THE WIRE. THERE WAS NO HARM REPORTED TO THE PATIENT AS A RESULT OF THE DELAY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 9 MM LATERAL ENTRY RECON NAIL (PART# UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), 6.5 MM RECON SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), PROTECTION SLEEVE (PART# 03.010.075, LOT# 32739, QUANTITY, 2), WIRE GUIDE (PART# 03.010.076, LOT# 32740, QUANTITY, 2), RADIOLUCENT INSERTION HANDLE (PART# 03.010.486, LOT# 9200411, QUANTITY 1), RADIOLUCENT RECON AIMING ARM (PART# 03.010.482, LOT# T988396, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178207 3.2MM GUIDE WIRE 400MM MISC ORTHO SURGICAL INSTR LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ONE INSERTION HANDLE, PART 03.010.486, LOT 9200411| ONE RECON AIMING ARM, PART 03.010.482, LOT T988396| ONE RECON NAIL, PART UNKNOWN, LOT UNKNOWN| RECON SCREWS, PART UNKNOWN, LOT UNKNOWN, QTY UNK| TWO PROTECTION SLEEVES, PART 03.010.075, LOT 32739| TWO WIRE GUIDES, PART 03.010.076, LOT 32740