BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISSECTOR, 4.0MM X 13CM

    MDR report key: 2860701 · Received December 6, 2012

    Report

    Report Number
    1220246-2012-00245
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    June 1, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE TYPICAL CAUSE OF THE EVENT IS WHEN THE USER APPLIES EXCESSIVE BENDING/LEVERAGING FORCE ON THE DEVICE DURING USE. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    THIS WAS REPORTED BY THE PATIENT WHO HAD SURGERY, A MENISECTOMY ON (B)(6) 2010. SHE BEGAN TO HAVE QUICK, SHARP RANDOM PAINS IN HER KNEE. SHE WENT TO HER DOCTOR AND HAD AN X-RAY. IT WAS NOTICED THERE WAS A FOREIGN BODY IN HER KNEE. SHE WENT BACK TO THE SURGEON (B)(6) 2012 AND HE REMOVED A METALLIC PIECE THAT WAS THE TIP OF THE OUTER SHAFT OF THE DISSECTOR. PATIENT DOING FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISSECTOR, 4.0MM X 13CM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other