BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY-LARGE TENDON STRIPPER, CLOSED

    MDR report key: 1051310 · Received May 23, 2008

    Report

    Report Number
    1219602-2008-00142
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 12, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE ACL RECONSTRUCTION PROCEDURE, THE STRIPPER BROKE OFF AND EMBEDDED IN THE POSTERIOR ASPECT OF THE HAMSTRING AND THEN TOWARDS THE BACK OF THE KNEE. SURGEON HAD TO USE X-RAY TO LOCATE THE BROKEN PART AND MAKE A LARGE INCISION IN THE PATIENT TO RETRIEVE THE PART. ANOTHER TENDON STRIPPER WAS USED TO COMPLETE THE PROCEDURE AND IT EXPERIENCED A DELAY OF 1.5 HOURS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSY-LARGE TENDON STRIPPER, CLOSED LARGE TENDON STRIPPER HRX SMITH & NEPHEW INC., ENDOSCOPY DIV. 7207179 50191017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK