BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.25MM KIRSCHNER WIRE, TROCAR POINTS ON BOTH ENDS

    MDR report key: 2491439 · Received March 7, 2012

    Report

    Report Number
    3003506883-2012-00044
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    December 2, 2011
    Report Date
    December 2, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HXI
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE WIRES CONFORM TO ALL DIMENSIONAL SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE PACKAGING DEVICE HISTORY SHOWS THAT THESE WIRES WERE PACKAGED IN A 10 PIECE PACKAGE WITH TIP PROTECTORS AT BOTH ENDS. THIS LOT WAS PACKAGED WITH NO ISSUES DOCUMENTED THAT WOULD LEAD TO THE COMPLAINT CONDITION.

    Description of Event or Problem · 1

    ACCOUNT REPORTED TO CONSULTANT: DURING INVENTORY CONTROL, AFTER COUNTING AND WHILE PUTTING THE K-WIRE PACKAGE BACK, ONE END OF THE K-WIRE PUNCTURED THROUGH THE PALM OF THE AND THE OTHER END PUNCTURED THROUGH THE FINGER OF HOSPITAL PERSONNEL. HOSPITAL PERSONNEL HAS BEEN BANDAGED UP AND THE BLEEDING HAS STOPPED. THE (3) K-WIRES PUNCTURED THE HOSPITAL PERSONNEL. THE (3) K-WIRES PUNCTURED THE RIGHT HAND AND (2) PUNCTURED THE LEFT HAND. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.25MM KIRSCHNER WIRE, TROCAR POINTS ON BOTH ENDS 1.25MM KIRSCHNER WIRE, TROCAR POINTS ON BOTH ENDS HXI SYNTHES ELMIRA 6696566

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention