BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSURE - PK

    MDR report key: 3613624 · Received February 7, 2014

    Report

    Report Number
    1219602-2014-00033
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Report Date
    January 9, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR ANALYSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE BIOSURE PK SCREW WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SCREW SHOWED THE DISTAL THREADS ARE ROLLED OVER. DIMENSIONAL INSPECTION CONFIRMED THE MAJOR DIAMETER AND LENGTH TO BE WITHIN PRINT SPECIFICATION. IN ADDITION THE BIOSURE SYNC DEVICE USED WITH THE SCREW WAS ALSO RETURNED FOR EVALUATION. THE SYNC WAS BROKEN IN FOUR PIECES AND ONE OF THE WINGS WAS NOT RETURNED. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE PRODUCT CAN BE DETERMINED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE DISCOMFORT AT THE INITIAL SURGICAL SITE. THE BIOSURE PK SCREW BACKED OUT OF THE SYNC DEVICE AND WAS SITTING IN THE PATIENT¿S SOFT TISSUE (ANTERIOR TIBIA). THE SCREW WAS REMOVED FROM THE PATIENT. THE SYNC DEVICE REMAINED IN THE TIBIAL CANAL BUT WAS REMOVED IN PIECES WITH A RONGEUR. PATIENT¿S BONE QUALITY WAS REPORTED AS ¿GOOD¿. TUNNEL SIZE WAS 9MM. SIZE DILATOR USED 9-10. SCREW AND SYNC WERE IMPLANTED ROUGHLY 6 MONTHS PRIOR TO REVISION. THE TUNNEL WAS PACKED WITH ALLOGRAFT CANCELLOUS CHIPS TO REVISE THE REPAIR. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED UPON COMPLETION OF THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79776 BIOSURE - PK BIOSURE PK, 9 X 25MM MBI MANSFIELD MANUFACTURING SITE 72202272 50477153

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention