BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIOTOME HATCHET DE

    MDR report key: 5031509 · Received August 26, 2015

    Report

    Report Number
    2523190-2015-00070
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 26, 2015
    Report Date
    July 29, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EIF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 9/15/2015 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULT: FAILURE ANALYSIS: PERIOTOME HATCHET IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS. ONE TIP BROKEN OFF. THIS COULD HAVE RESULTED IN IMPROPER USAGE DAMAGE FROM APPLYING TOO MUCH PRESSURE CAUSING THE TIP TO BREAK OFF. 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: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT REPORT HAS BEEN CONFIRMED, THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP MATERIAL DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE TIP BROKE OFF WHILE USING - NO INJURY OCCURRED. (B)(6) 2015, CUSTOMER REPORTS THE DOCTOR WAS PERFORMING A TOOTH EXTRACTION. THE DOCTOR WAS INSERTING TIP BETWEEN THE TOOTH & PERIODONTAL LIGAMENT AND IT BROKE OFF IN THE PATIENTS MOUTH, USED GAUZE TO REMOVE IT. PER DOCTOR, USED PREVENTATIVE MEASURES, GAUZE, SO PATIENT DID NOT SWALLOW TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566592 PERIOTOME HATCHET DE M54 - ORAL SURGERY EIF INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1