BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSURE HA SCREW

    MDR report key: 2500533 · Received March 22, 2012

    Report

    Report Number
    1219602-2012-00063
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 24, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. EVALUATION OF THE RETURNED SCREW CONFIRMED THE REPORTED COMPLAINT OF A REVERSE SCREW. A CLASS II VOLUNTARY RECALL WAS INITIATED ON (B)(4) 2012 ON PRODUCT 72201772 LOT 50397157 WITH THE ISSUE OF INCORRECT THREAD SCREW. (B)(4).

    Description of Event or Problem · 1

    INSTEAD OF NORMAL THREAD THERE WAS A REVERSE THREAD SCREW IN THE PACKAGE. DURING A MPFL RECONSTRUCTION PROCEDURE, SCREW (72201772 BIOSURE HA) CUT THE LIGAMENT AND THE TENDON WAS PARTIAL DAMAGE. SURGEON SUTURED A PIECE OF THE QUADRICEPS LIGAMENT TO THE ORIGINAL LIGAMENT AND FIX THE GRAFT INTO THE BONE WITH ANOTHER SCREW TO COMPLETE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSURE HA SCREW BIOSURE HA , 7MM X 25MM HWC SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72201772 50397157

    Patients

    Seq Age Sex Outcome Treatment
    1