BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1

    MDR report key: 5073082 · Received September 12, 2015

    Report

    Report Number
    1219602-2015-01002
    Event Type
    Malfunction
    Date Received
    September 12, 2015
    Date of Event
    May 23, 2014
    Report Date
    February 11, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    PMA / PMN Number
    K992396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SCR, BIORCI 7X25MM (8MM HEAD) WAS RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT MODE, ¿BROKEN SCREW.¿ VISUAL INSPECTION CONFIRMED THE REPORTED COMPLAINT; THE SCREW WAS BROKEN INTO SEVERAL PIECES. BASED ON THE DETAILS OF THE COMPLAINT, THE LIKELY CAUSE OF THE SCREW BREAKING IS DUE A LACK OF HOLE PREPARATION PRIOR TO SCREW INSERTION. PER IFU 1060635, ¿THE STARTER MUST BE UTILIZED WITH THE BIORCI SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION.¿ DUE TO THESE OBSERVATIONS NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CAN BE ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    INDIVIDUAL MDR SUBMISSION NOT REQUIRED. THIS EVENT WAS PREVIOUSLY FILED UNDER ASR (B)(4) ON JULY 31, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ART KNEE PROCEDURE USING SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1 THE DISTAL END OF THE SCREW BROKE. DEBRIS WAS REMOVED FROM THE PATIENT. THERE WAS A PROCEDURAL DELAY OF 3.5 HOURS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THIS INCIDENT DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604410 SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1 SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 50406116

    Patients

    Seq Age Sex Outcome Treatment
    1