BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, RIGHT, SHORT

    MDR report key: 3183086 · Received June 21, 2013

    Report

    Report Number
    0008010177-2013-00129
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE PARTIALLY CONFIRMED BECAUSE ONE SCREW IS BROKEN/FRACTURED, BUT THE PLATE DOES NOT SHOW ANY TORN SIGNS. VISUAL INVESTIGATION SHOWED THAT TOO HIGH BENDING FORCES ACTED ON THE PLATE DURING APPLICATION. THESE BENDING FORCES LED TO HIGH TRACTION FORCES BEING APPLIED ON THE SCREW AND CAUSED ITS BREAKAGE. THE FRACTURED SURFACES HAD THE APPEARANCE OF A FORCED RUPTURE WITH SECONDARY CRACKS CAUSED BY HIGH TRACTION FORCES. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A POWERFUL DYNAMIC OVERLOAD OF THE FRACTURE. FURTHERMORE, IN THE CLINICAL OPINION IT WAS STATED THAT THERE IS AN UNSTABLE FRACTURE WITH BIG DORSAL BONE DEFECT IN THE AREA OF THE DISTAL RADIUS AND A BREAK OF THE STYLOID PROCESS. THE FRACTURE WAS STABILIZED WITH A VERY SMALL PALMAR VARIAX PLATE. ALSO, STABILIZATION OF THE BROKEN STYLOID PROCESS WAS PERFORMED WITH A K-WIRE. A DELAYED UNION OR A NON-UNION OCCURRED. FURTHER, THE DISTAL FRAGMENT NON-UNION WAS COMPRESSED UNDER LONG LASTING OVERLOADS AND THEREBY BREAKAGE OF THE PROXIMAL SCREW OCCURED IN THE AREA OF THE SCREW HEAD. NO INDICATIONS WERE FOUND FOR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT FOLLOWING THE IMPLANT OF A DISTAL RADIUS PLATE MATRIX, THE IMPLANT WAS TORN CAUSING BREAKAGE OF A SCREW. THE SCREW STAYED INTO THE BONE AND CROSSED THE PLATE.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT FOLLOWING THE IMPLANT OF A DISTAL RADIUS PLATE MATRIX, THE IMPLANT WAS TORN CAUSING BREAKAGE OF A SCREW. THE SCREW STAYED INTO THE BONE AND CROSSED THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283928 PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, RIGHT, SHORT IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1