BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL RING, 220MM, TL-HEZ STERILE

    MDR report key: 4346732 · Received December 3, 2014

    Report

    Report Number
    9680825-2014-00027
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 4, 2014
    Report Date
    December 3, 2014
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K141078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-56-20080 LOT V1323055 (COMPONENT CODE 56-20080N LOT V1294882) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2012, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO OUR HISTORICAL RECORDS, NO OTHER SIMILAR FAILURES HAVE BEEN REPORTED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT IS STILL IN USE BY PATIENT. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE IS AVAILABLE. MEDICAL EVALUATION: THE LITTLE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION IS CURRENTLY ONGOING AND WILL BE FINALIZED ONCE FURTHER INFORMATION ON THE CASE WILL BE AVAILABLE. ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS COPY OF THE OPERATIVE REPORT, COPY OF THE PRE AND POST-OPERATIVE X-RAYS, INFORMATION ON PATIENT CURRENT HEALTH CONDITION AND THE DEVICE AVAILABILITY FOR THE TECHNICAL EVALUATION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2014; BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FOOT; SURGERY DESCRIPTION: CORRECTION; PATIENT INFORMATION: FEMALE, (B)(6); PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; EVENT DESCRIPTION: STRUTS DO NO SIT FLUSH IN RELATION WITH INDICATION MARKINGS ON MOUNTING STUD TO MOUNTING HOLE OF RING. THIS CAUSES THE TWO STRUTS TO EASILY POP OUT OF RING. A DIFFERENT STRUT WAS INSERTED WITH TE SAME RESULT. SURGERY COMPLETED WITH USED DEVICE: CABLE TIES HAD TO BE USED TO KEEP STRUT IN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779446 FULL RING, 220MM, TL-HEZ STERILE FULL RING, 220MM, TL-HEX STERILE KTT ORTHOFIX SRL 99-56-20080 V1323055

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR