BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLINT FOR RIB FIXATION SYSTEM

    MDR report key: 3003686 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10377
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K081623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. VISUAL EXAMINATION NOTED THE DEVICE WAS BROKEN. CALIPER AND MICROMETER WERE USED TO VERIFY DIMENSION SPECIFICATIONS. THE INVESTIGATION FOUND NO MANUFACTURING RELATED FAULT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A RIB SPLINT (04.501.010) BROKE AFTER BEING BENT TO INSERT INTO THE RIB CANAL SPACE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING ANOTHER SPLINT. THE BROKEN IMPLANT WAS EASILY REMOVED BY BACKING IT OUT OF THE BONE. THE INCIDENT DID NOT PROLONG THE SURGERY. NO ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86933 SPLINT FOR RIB FIXATION SYSTEM HRS SYNTHES GMBH 3144297

    Patients

    Seq Age Sex Outcome Treatment
    1