BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERTAN

    MDR report key: 2012372 · Received March 9, 2011

    Report

    Report Number
    1020279-2011-00070
    Event Type
    Injury
    Date Received
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE ANALYSIS CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE TRIGEN INTERTAN NAIL FRACTURED BY THE INITIATION AND SUBSEQUENT PROPAGATION OF FATIGUE CRACKING . THE FRACTURE MOST LIKELY INITIATED ON THE LATERAL SIDE OF THE NAIL. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE REMAINING CROSS-SECTIONAL AREA OF THE NAIL COULD NOT BEAR THE IMPOSED PATIENT LOADING, WHICH LEAD TO AN OVERLOAD FRACTURE. FATIGUE CRACKING IS CAUSED BY THE NAIL BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS, INCLUDING BUT NOT LIMITED TO (1) EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION, (2) APPLICATIONS OF LOADS IN EXCESS OF THE MATERIAL'S STRENGTH, AND/OR (3) POOR BONE QUALITY. NO MATERIAL DEVIATIONS IN THE NAIL WERE FOUND DURING THIS INVESTIGATION. DEFORMATION IS OBSERVED ON THE EDGE OF THE SET SCREW, INDICATING THAT THE LAG SCREW AND COMPRESSION SCREW WERE LOCKED, AS INDICATED IN THE REPORTED COMPLAINT. IT WAS ALSO CONCLUDED THAT THE TRIGEN 5.0 MM SCREW FRACTURED BY THE INITIATION AND SUBSEQUENT PROPAGATION OF FATIGUE CRACKING. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE REMAINING CROSS-SECTIONAL AREA OF THE NAIL COULD NOT BEAR THE IMPOSED PATIENT LOADING, WHICH LEAD TO AN OVERLOAD FRACTURE. FATIGUE CRACKING IS CAUSED BY THE SCREW BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS, INCLUDING BUT NOT LIMITED TO (1) EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION, (2) APPLICATIONS OF LOADS IN EXCESS OF THE MATERIAL'S STRENGTH, AND/OR (3) POOR BONE QUALITY. NO MATERIAL DEVIATIONS IN THE SCREW WERE FOUND DURING THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED NAIL FRACTURED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERTAN INTERTAN 1.5 11.5MMX40CM 125D RT JDS SMITH & NEPHEW ORTHOPAEDICS, INC. 71676560 10FM18645

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PRODUCT # 71677100 LOT # 10HM13803