BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-LOC

    MDR report key: 1882622 · Received October 26, 2010

    Report

    Report Number
    1020279-2010-00301
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE ANALYSES CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE 2.7/3.5 MM POSTERIORLATERAL DISTAL HUMERUS LOCKING PLATE FRACTURED BY METAL FATIGUE CRACKING. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE REMAINING CROSS-SECTIONAL AREA OF THE PLATE COULD NOT BEAR THE IMPOSED PATIENT LOADING, LEADING TO OVERLOAD FRACTURE. FATIGUE CRACKING IS CAUSED BY THE PLATE 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 EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION. NO MATERIALS OR MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE FRACTURED REQUIRING A REVISION SURGERY TO CORRECT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REQUESTING ASSISTANCE WITH STARTING OVER WITH NEW SUPPLIES ON THE HOME CHOICE (HC) MACHINE. THE HP EXPLAINED HE MAY HAVE CONTAMINATED THE PATIENT LINE CONNECTING THE EXTENSION LINE AND WANTED TO START OVER WITH NEW SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE HAD THE HP CYCLE POWER TO START OVER WITH NEW SUPPLIES. A FOLLOW UP WITH THE CARE GIVER (CG) WAS DONE BY PHONE. THE CG SAID THEY WERE TOLD BY BAXTER NOT TO TAKE ANY CHANCES AND TO START OVER WITH NEW SUPPLIES. PER THE CG, THEY SET UP WITH NEW SUPPLIES AND THE HP CONTINUED THERAPY WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-LOC PLATE HRS SMITH & NEPHEW, INC. 08KM04793

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R