BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARB-BITE STERNAL NH 7-3/4

    MDR report key: 4924646 · Received July 16, 2015

    Report

    Report Number
    2523190-2015-00038
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 22, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 8/18/15 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE PRODUCT WAS NOT RETURNED FOR REVIEW. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER (B)(4) - EVENT DESC: SURGEON USING BULLDOG JARIT 121-260 CARB-BITE TO REMOVE ABX SPACER WHEN A PIECE OF THE TIP BROKE OFF. MAJORITY WAS REMOVED, X-RAY TAKEN AND NO OBJECT NOTED. ON (B)(6) 2015 CUSTOMER REPORTS THAT "THE PATIENT HAD A REMOVAL OF ANTIBIOTIC SPACER, SEQUESTRECTOMY OF OSTEOMYELITIS, AND INTRAMEDULLARY NAILFIXATION OF HER RIGHT FEMUR. THE SURGEON WAS USING A TYPE OF NEEDLE HOLDER, CALLED A "BULLDOG" NEEDLE HOLDER (JARIT 121-260) TO TRY TO EXPLANT A SPACER WHICH HAD GOTTEN CAUGHT IN BONE, WHILE IN USE. IN THE PROCESS OF PULLING THIS METAL PIECE OUT, THE TIP OF THE NEEDLE HOLDER BROKE. THEY WERE ABLE TO LOCATE THE LARGER OF THE TWO FRAGMENTS OF NEEDLE HOLDER, BUT NOT THE SMALLER. A FLATE PLATE X-RAY WAS TAKEN AND EXAMINED BY BOTH THE SURGEON AND THE RADIOLOGIST AND NO RETAINED SURGICAL ITEMS WERE NOTED IN THE WOUND. THE SMALLER PIECE OF THE NEEDLE HOLDER WAS NOT VISIBLE ON THE FILM AND WAS MOST LIKELY WAS WASHED AWAY BY COPIOUS IRRIGATION AND SUCTIONING OF THE WOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463639 CARB-BITE STERNAL NH 7-3/4 NA GDF INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR