BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL TIBIAL JTS

    MDR report key: 6128314 · Received November 28, 2016

    Report

    Report Number
    3004105610-2016-00092
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO COMPLAINTS AND IN RECOGNITION OF CUSTOMER/SURGEON PREFERENCE, STANMORE IMPLANTS WORLDWIDE (SIW) HAS CONDUCTED AN ASSESSMENT OF ITS CURRENT INSTRUMENT KIT DESIGN TO DETERMINE POTENTIAL IMPROVEMENTS AND TO IDENTIFY THE NEED FOR PROVIDING ADDITIONAL INSTRUMENTATION AS PART OF AN UPGRADE KIT. INITIAL RECOMMENDATIONS HAVE BEEN COMPLIED PENDING FINAL APPROVAL AND IMPLEMENTATION. THIS COMPLAINT WAS DUE TO SURGEON PREFERENCE, NO PRODUCT PROBLEM WAS IDENTIFIED. THIS COMPLAINT FILE WAS REVIEWED AS PART OF SIW COMPLAINT FILE REMEDIATION PROGRAMME AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED. THIS COMPLAINT WAS RECEIVED BY SIW IN MARCH, 2013.

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO COMPLAINTS AND IN RECOGNITION OF CUSTOMER/SURGEON PREFERENCE, STANMORE IMPLANTS WORLDWIDE (SIW) HAS CONDUCTED AN ASSESSMENT OF ITS CURRENT INSTRUMENT KIT DESIGN TO DETERMINE POTENTIAL IMPROVEMENTS AND TO IDENTIFY THE NEED FOR PROVIDING ADDITIONAL INSTRUMENTATION AS PART OF AN UPGRADE KIT. INITIAL RECOMMENDATIONS HAVE BEEN COMPLIED PENDING FINAL APPROVAL AND IMPLEMENTATION. THIS COMPLAINT WAS DUE TO SURGEON PREFERENCE, NO PRODUCT PROBLEM WAS IDENTIFIED. THIS COMPLAINT FILE WAS REVIEWED AS PART OF SIW COMPLAINT FILE REMEDIATION PROGRAMM AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED. THIS COMPLAINT WAS RECEIVED BY SIW IN MARCH, 2013. CAPA HAS BEEN OPENED. A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE DRILL GUIDE SPUN OFF THE BONE DURING DRILLING. EXAMINATION OF THE DRILL REVEALED CIRCUMFERENTIAL SCRATCHES. NO REAMERS WERE PROVIDED. THE STEM OF THE IMPLANT WAS TOO TIGHT AND THE TIBIA WAS SITTING PROUD. STANMORE REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE DRILL GUIDE SPUN OFF THE BONE DURING DRILLING. EXAMINATION OF THE DRILL REVEALED CIRCUMFERENTIAL SCRATCHES. NO REAMERS WERE PROVIDED. THE STEM OF THE IMPLANT WAS TOO TIGHT AND THE TIBIA WAS SITTING PROUD. STANMORE REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779614 PROXIMAL TIBIAL JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 17650 PIN 17650

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other