BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRISTORE DISTAL RADIUS FRACTURE FIXATOR

    MDR report key: 2042237 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00549
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 11, 2010
    Report Date
    March 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED FIXATOR BODY IS CRACKED AT THE BOTTOM OF THE DOVETAIL SLIDE NEAR THE SCREW AREA. THE SCREW CAN BE ROTATED FREELY IN THE HOLE WHICH ELIMINATES THE POSSIBILITY OF DAMAGE DUE TO CROSS THREADING. ALL THE SCREWS IN THIS DEVICE ARE INTENDED TO ARREST THE MOTION OF EITHER THE K-WIRE OR OTHER SUBASSEMBLY. DEPENDING ON THE LOCATION OF THE DORSAL OUTRIGGER INSIDE THE DOVETAIL SLIDE, THE SCREW WHERE THE FRACTURE HAS OCCURRED ACTS AS A STOPPER FOR THE SLIDE OR HOLDS THE DORSAL OUTRIGGER IN POSITION. IF THE SCREW HOLDS THE DORSAL OUTRIGGER, THERE IS NO CONTACT BETWEEN THE SCREW HEAD AND THE FIXATOR BODY. THIS CONDITION WILL NOT RESULT IN FRACTURE OF THE BODY. WHEN THE SCREW IS USED AS A STOPPER FOR THE DORSAL OUTRIGGER AND IF THE SCREW IS OVER TIGHTENED, THE ENTIRE LOAD WILL BE BORNE BY THE FIXATOR BODY. THIS CONDITION MAY LEAD TO CRACKING OF THE BODY. BASED ON AVAILABLE INFO, IT APPEARS THAT THE EXCESSIVE TORQUE APPLIED ON THE SCREW MAY BE THE CONTRIBUTING FACTOR FOR THE CRACK; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFO. THE SURGICAL TECHNIQUE WARNS NOT TO OVER TIGHTEN THE SCREWS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR A CRACK THAT WAS FOUND AT THE SCREW HOLE OF THE DOVETAIL SLIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRISTORE DISTAL RADIUS FRACTURE FIXATOR KTT ZIMMER, INC. 61148077

    Patients

    Seq Age Sex Outcome Treatment
    1