BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREER SEPTUM ELEVATOR

    MDR report key: 1507852 · Received October 1, 2009

    Report

    Report Number
    1226348-2009-00258
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 23, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. ONE SIDE OF THE SHAFT WAS BROKEN OFF APPROXIMATELY 3/4 INCH FROM THE TIP. THE FRACTURED SURFACE OF THE DEVICE REVEALED EVIDENCE OF CORROSION. THIS TYPE OF FRACTURE/BREAKAGE TYPICALLY OCCURS DUE TO USE/WEAR OVER A PROLONGED PERIOD OF TIME (THIS INSTRUMENT IS APPROXIMATELY 9 YEARS OLD AND OUT OF WARRANTY). IT COULD ALSO OCCUR WHEN THERE HAS BEEN A SMALL CRACK IN THE MATERIAL BROUGHT ABOUT BY EITHER OVERLY AGGRESSIVE USE/ABUSE OF THE INSTRUMENT OR THROUGH A MANUFACTURING ERROR IN THE ORIGINAL SETTING OR BENDING OF THE INSTRUMENT. SUBSEQUENT CORROSION AND STRESSING OF THE CRACKED SITE APPEARS TO HAVE BROUGHT ABOUT THE FAILURE NOTED. IT IS NOT POSSIBLE TO DETERMINE HOW THE ORIGINAL CRACK WAS FORMED. THIS APPEARS TO BE OCCURRING WITHIN EXPECTED LIMITS FOR THIS TYPE OF PROBLEM. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS NEEDED AS A RESULT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PRODUCT, THEREFORE; IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. ADDITIONAL INFO FROM THE USER FACILITY REPORT: PT: MALE. CODMAN FREER ELEVATOR, DEVICE AVAILABLE FOR EVAL: DATE USER FACILITY OR IMPORTER BECAME AWARE OF EVENT: 2009. DATE OF THIS REPORT: 09/23/09. REPORT SENT TO FDA? NO. REPORT SENT TO MFR? YES. 09/23/09.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT "DURING A RIGHT FOOT SURGERY (BONE GRAFT) THE INSTRUMENT BROKE IN TWO PIECES CAUSING LACERATION. PT REQUIRED A COUPLE OF SUTURES AND WAS OKAY AFTER SURGERY. NO SIGNIFICANT DELAY IN SURGERY VERIFIED". ADDITIONAL INFO FROM THE USER FACILITY REPORT: IN 2009, DURING BASKETBALL PRACTICE, THE PT REFRACTURED THE LATERAL AND INTERIOR CORTEX OF THE RIGHT FOOT. DURING THE RIGHT METATARSAL BONE GRAFT PROCEDURE, THE FREER ELEVATOR BROKE INTO TWO PIECES. THE INSTRUMENT SLIPPED OFF THE BONE AND CAUSED TWO SMALL LACERATIONS TO THE SKIN ON THE RIGHT LATERAL ANKLE (1/8 - 1/4 INCH IN SIZE). THE LACERATIONS WERE SUTURED, AND THE PT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREER SEPTUM ELEVATOR ELEVATOR, SURGICAL, GENERAL, & PLASTIC SURGERY GEG CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R