BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED HEALING - B

    MDR report key: 2781379 · Received October 10, 2012

    Report

    Report Number
    1219602-2012-00261
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    July 30, 2012
    Report Date
    August 24, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREW WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THAT THE DISTAL TIP IS BROKEN OFF. THE MAJOR DIAMETER OF THE SCREW WAS MEASURED AND FOUND TO BE WITHIN PRINT SPECIFICATION. THE DETAILS OF THE CASE STATE THAT THE SURGEON DOES NOT FOLLOW THE RECOMMENDED SITE PREP AND INSERTION TECHNIQUE PER THE IFU. GIVEN THE PHYSICAL EVIDENCE AND THE CLINICAL DETAILS PROVIDED, NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    BONE BLOCK FEMORAL PRESSED BY A BONE BRIDGE BRINGING IN BIOSURE A FEW MM ASIDE; NO STARTER USED, NO TAP; DEVICE BROKE DISTAL PART. DRIVER WAS SEATED PROPERLY IN SCREW, PROPER SCREWDRIVER WAS USED AND FURTHER BONE BRIDGE WAS USED AND PRESSED WITH A MILAGRO SCREW INSERTER. NO LOT NUMBER FOR THE DEVICE WAS PROVIDED. ADDITIONAL INFORMATION: ALL PIECES WERE REMOVED USING A GRASPER AND SHAVER. PHYSICIAN IS CONFIDENT ALL FRAGMENTS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED HEALING - B BIOSURE HA, 8 X30MM HWC SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72201778

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR