BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUGGLES HAND-HELD SILICONE BRAIN RETRACTOR

    MDR report key: 2423227 · Received January 17, 2012

    Report

    Report Number
    2523190-2012-00009
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    August 24, 2011
    Report Date
    January 17, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE FROM THE USER FACILITY SAID SHE COULD NOT BE CERTAIN THAT THE FRAGMENT THAT WAS RETAINED IN THE PT'S FOOT WAS FROM THE RUGGLES RETRACTOR. SHE REPORTED THAT SOMEONE FROM THE STERILE PROCESSING DEPARTMENT THOUGHT THE 2 CENTIMETER X 2 MILLIMETER FRAGMENT MIGHT HAVE BEEN THE TIP OF THE RUGGLES RN0711 RETRACTOR THAT MAY HAVE BEEN SAWED OFF BY THE OSCILLATING SAW DURING THE SURGICAL PROCEDURE. HOWEVER, THE NURSE REPORTED THAT ALL INSTRUMENTS ON THE POST-OPERATIVE TRAY WERE INTACT AND ALL OF THE RETRACTORS AT THE FACILITY WERE FOUND TO BE INTACT. AN ATTEMPT TO OBTAIN ADD'L INFO AS WELL AS THE REPORTED FRAGMENT FOR INVESTIGATION HAS BEEN MADE BY INTEGRA. THE REPORTING FACILITY HAS COMMUNICATED THAT THEY WILL NOT RETURN THE FRAGMENT FOR INVESTIGATION AND WILL NOT PROVIDE ANY FURTHER ADD'L F/U INFO. THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE NURSE STATED THE PT HAD A BUNIONECTOMY PERFORMED AT THE REPORTING FACILITY ON (B)(6), 2011. FOLLOWING SURGERY, THE PT EXPERIENCED PAIN IN HER FOOT THAT DID NOT SUBSIDE. AN MRI OF THE PT'S FOOT WAS PERFORMED WHICH REVEALED THE PRESENCE OF A FOREIGN BODY 2 CENTIMETERS X 2 MILLIMETERS THAT WAS SUBSEQUENTLY REMOVED AT A DIFFERENT FACILITY "ABOUT 1 MONTH AGO" BY THE SAME PODIATRIST WHO PERFORMED THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUGGLES HAND-HELD SILICONE BRAIN RETRACTOR RETRACTORS GAD INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention