BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER ANCHOR

    MDR report key: 2760893 · Received September 26, 2012

    Report

    Report Number
    1219602-2012-00255
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 31, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLASS II RECALL WAS INITIATED ON AUGUST 6, 2012 FOR THE PACKAGE INTEGRITY ISSUE. (B)(4).

    Description of Event or Problem · 1

    E-MAIL REPORTING A NEW CUSTOMER`S CLAIM ABOUT AN INFECTION OF A SHOULDER AFTER A SURGERY WITH TWINFIX AND FOOTPRINT ANCHORS. MULTIPLE REVISIONS WERE PERFORMED TO DEBRIDE, LAVAGE AND REMOVE INFECTIOUS MATERIAL AND ANCHOR. BELOW IS SURGEON'S SHORT SUMMARY REPORTS ON COURSE OF OCCURRENCE ON (B)(6) 2011: DIAGNOSIS OF RUPTURE OF ROTATOR CUFF. ON (B)(6) 2011: SURGERY AT (B)(6) USE OF TWO TWINFIX TITANIUM AND FOOT PRINT ANCHOR (PEEK). NO SPECIAL PARTICULARITIES, BUT FLUSH OF LEFT EYE. ON (B)(6) 2011: PUNCTURE OF SHOULDER AFTER GROWING PAIN. SANGUINEOUS-SEROUS MATERIAL RETRIEVED OUT OF THE JOINT. ON (B)(6) 2011: ARTHROSCOPIC REVISION DUE TO REMAINING PAIN. LAVAGE BETWEEN (B)(6) 2011 AND (B)(6) 2012 DIAGNOSIS: 'INFECTION OF SHOULDER.' ON (B)(6) 2012: REVISION SURGERY, DEBRIDEMENT AND LAVAGE OF SHOULDER JOINT. ON (B)(6) 2012: SURGERY DUE TO FLUSH AND SWELLING OF SHOULDER. STAB INCISION IN SHOULDER LAVAGE. NO PURULENCE. ON (B)(6) 2012: BURSECTOMY SURGERY: ARTHROSCOPIC REMOVAL OF ONE ANCHOR. SHOW SIGNS OF INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOULDER ANCHOR TWINFIX TI MBI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention