BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50

    MDR report key: 6680312 · Received June 30, 2017

    Report

    Report Number
    3005180920-2017-00350
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    June 2, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 JULY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE PIECE WAS ANALYZED. THE SCREW IS BENT IN THE PART CLOSED TO THE SCREW HEAD. IT IS NOT CLEAR HOW IT WAS HAPPENED AND WE CAN NOT DETERMINATE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, BUT WE CAN ASSUME THAT IT IS DUE TO AN ERRONEOUS USE DURING SURGERY: IN ORDER TO CORRECT THE DIRECTION OF INSERTION, THE SURGEON WOULD HAVE APPLIED A FORCE IN FLEXION TO PROVIDE THE BENDING OF THE ACETABULAR SCREW.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 09 JUNE 2017 AND INCLUDES: IF THE SURGEON CONTINUED TO TIGHTEN THE SCREW, HE WOULD HAVE BROKEN IT. THE SURGEON USED THE UNIVERSAL HANDLE. BATCH REVIEW PERFORMED ON 26 JUNE 2017. LOT 132489: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET RECEIVED.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS IMPLANTING THE SCREW, THE SCREW BENT. THE SURGEON USED A SMALLER SCREW TO COMPLETE THE SURGERY. THERE WAS A SHORT DELAY OF LESS THAN 2 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE; IMPLANT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460885 MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50 CANCELLOUS BONE SCREW LPH MEDACTA INTERNATIONAL SA 132489

    Patients

    Seq Age Sex Outcome Treatment
    1 Other