BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE, ADJUSTABLE

    MDR report key: 3111737 · Received May 7, 2013

    Report

    Report Number
    3004608878-2013-00089
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE TIP OF THE DEVICE BROKE WHILE MEASURING THE SCREW DURING SURGERY. THE TIP OF THE DEVICE WAS VISUALIZED AND COMPLETELY REMOVED WITH A FORCEPS AND WAS DISCARDED. THE DOCTOR COMPLETED THE SURGERY WITHOUT USE OF A DEPTH GAUGE WHICH CAUSED THE SURGERY TIME TO BE EXTENDED BY 20-30 MINUTES. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199893 DEPTH GAUGE, ADJUSTABLE SPIDER LIMITED WRIST FUSION SYSTEM HRS INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1