BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOTOME CP313-1 GUARDED 3.0MM BECKER

    MDR report key: 6011016 · Received October 7, 2016

    Report

    Report Number
    2523190-2016-00160
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 12, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GFI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    10/13/16 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - ONE OSTEOTOME RETURNED IN USED CONDITION SHOWING MINIMAL WEAR.. THE ANALYSIS OF THE INSTRUMENT SHOWS THAT THERE IS SLIGHT STAINING WITHIN THE FINISH AND THE TIP IS BROKEN. WITHOUT KNOWING HOW THE INSTRUMENT WAS HANDLED DURING USE, THE CAUSE IS UNDETERMINED. THE COMPLAINT REPORT IS CONFIRMED. DEVICE HISTORY EVALUATION - NO NONCONFORMITY FOR THIS LOT. NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE CONCLUSION: THE ROOT CAUSE OF THE DAMAGE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY. THE CAUSE OF THIS DAMAGE IS A FALL (DROPPED).

    Additional Manufacturer Narrative · 1

    ON 9/21/2016 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - ONE OSTEOTOME RETURNED IN USED CONDITION, SHOWING MINIMAL WEAR, STAINING WITHIN THE FINISH AND BROKEN TIP. DURING THE ANALYSIS OF THE INSTRUMENT, IT IS NOTICED THAT THERE IS SLIGHT STAINING WITHIN THE FINISH AND THE TIP IS BROKEN. WITHOUT KNOWING HOW THE INSTRUMENT WAS HANDLED DURING USE, THE CAUSE IS UNDETERMINED. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE ROOT CAUSE OF THE DAMAGE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS TIP HAS BROKEN OFF. ON (B)(6) 2016 CUSTOMER REPORTS A RHINOPLASTY & SEPTOPLASTY WERE BEING PERFORMED WHEN THE TIP BROKE OFF AND FELL ON THE FLOOR. NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664198 OSTEOTOME CP313-1 GUARDED 3.0MM BECKER PFM11 GFI INTEGRA YORK, PA INC. 1369629 / 141002

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR