BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR AB 2.9 MM

    MDR report key: 2152050 · Received July 7, 2011

    Report

    Report Number
    1219602-2011-00108
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 22, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE INSERTER WAS RETURNED FOR EVALUATION. INSERTER SHAFT IS SLIGHTLY BOWED. MEASUREMENT OF THE INSERTER SHAFT CONFIRMED IT WAS MANUFACTURED PRIOR TO (B)(4) WHICH REDUCED THE DIMENSIONS AT THE DISTAL END OF THE SHAFT TO ELIMINATE THE INTERFERENCE BETWEEN THE ANCHOR AND THE INSERTER ON THE 2.9 BIORAPTOR SUTURE ANCHORS. (B)(4).

    Description of Event or Problem · 1

    PRODUCT BROKE INTO THE SHOULDER OF THE PATIENT DURING CASE. PER MALFUNCTION REPORT: PIECE REMOVED FROM PATIENT. E-MAIL RECEIVED CONFIRMED PATIENT HAD GOOD BONE AND THAT THE SURGEON USED A 3.0MM DRILL TO PREP SITE. ANCHOR BROKE AT EYELET AND USED AN ALTERNATIVE DEVICE TO COMPLETE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIORAPTOR AB 2.9 MM BIORAPTOR 2.9 WITH 2 ULTRABRAID HWC SMITH & NEPHEW ENDOSCOPY 72200775 50343001

    Patients

    Seq Age Sex Outcome Treatment
    1