BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF RETAINING TORX DRIVER FOR 2.7 MM SURFIX NEWDEAL TIP

    MDR report key: 3901640 · Received May 6, 2014

    Report

    Report Number
    3004608878-2014-00054
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A WRIST FUSION SURGERY, THE SURGEON INSERTED A 2.7 SURFIX SCREW ((B)(4)) INTO THE MOST DISTAL HOLE ON THE WRIST FUSION PLATE ((B)(4)) AFTER HE DRILLED WITH THE 2.0 DRILL BIT ((B)(4)). WHEN TIGHTENING THE SCREW DOWN (WITH THE SCREW DRIVE) THE TIP OF THE SCREW DRIVE ((B)(4)) BROKE OFF INSIDE THE SCREW. THE SMALL FRAGMENT OF SCREW DRIVER TIP WAS NOT ABLE TO BE REMOVED. IT WAS LEFT INSIDE OF THE HEAD OF THE 3.7 SCREW. THE SURGEON WAS UNABLE TO PUT A LOCK WASHER ON TOP OF THE SCREW TO LOCK IT. THERE WAS NO REPORTED INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271596 SELF RETAINING TORX DRIVER FOR 2.7 MM SURFIX NEWDEAL TIP WRIST FUSION INSTRUMENTS HRS INTEGRA LIFESCIENCES CORPORATION JG0034

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR