BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUCIFORM SCREWDRIVER

    MDR report key: 3031978 · Received April 3, 2013

    Report

    Report Number
    2530088-2013-00522
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD BE RELEVANT TO THE COMPLAINT CONDITION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THAT ONE OF THE FOUR CRUCIFORM TIPS WAS SHEARED OFF AND WAS NOT RETURNED FOR EVALUATION. THE REMAINING 3 CRUCIFORM TIPS ARE SIGNIFICANTLY WORN AND DISCOLORED (GREY TO BLACK). A SMALL PORTION OF THE RED COLOR CODE BAND HAS WORN OFF. THE RETURNED DEVICE (CRUCIFORM SCREWDRIVER, PART: 313.96.96, LOT: A4HJ291) WAS MADE FROM ACCEPTABLE MATERIAL FOR MAKING SCREWDRIVER SHAFTS/BLADES. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: DURING SURGERY ON (B)(6) 2013 FOR A RIGHT TIBIA/FIBULA REPEAT INCISION AND DRAINAGE, THE HEAD OF THE SCREWDRIVER BROKE. ALL PIECES WERE RETRIEVED. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136877 CRUCIFORM SCREWDRIVER HXX SYNTHES BRANDYWINE A4HJ291

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR