BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUP DIST CLAV LK PL L 109MM

    MDR report key: 7452711 · Received April 23, 2018

    Report

    Report Number
    1020279-2018-00800
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    May 25, 2017
    Report Date
    January 29, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    00885556042120
    PMA / PMN Number
    K061352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PERI-LOC SUPERIOR DISTAL CLAVICLE PLATE ALONG WITH SIX SCREWS WERE RETURNED AND EVALUATED. FROM THE ANALYSIS CONDUCTED DURING THIS INVESTIGATION, THE LAB ANALYSIS CONCLUDED THAT THE PLATE 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 LOCKING PLATE COULD NOT BEAR THE IMPOSED PATIENT LOADING, WHICH LEAD TO AN 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, APPLICATIONS OF LOADS IN EXCESS OF THE MATERIAL¿S STRENGTH, AND/OR POOR BONE QUALITY. NO MATERIAL DEVIATIONS IN THE LOCKING PLATE WERE FOUND DURING THIS INVESTIGATION. A CLINICAL EVALUATION NOTED THE RADIOGRAPHIC IMAGES PROVIDED CONFIRM THE BROKEN PLATE AS WELL THE DEFORMITY OF THE CLAVICLE BENEATH THE PLATE. A NON-UNION CANNOT BE RULED OUT BASED ON THE LIMITED QUALITY OF THE PROVIDED IMAGES. OUR INVESTIGATION INCLUDING A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED FAILURE MODE WITH THE SAME BATCH NUMBER. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LISTED BATCH DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE ON A PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294206 SUP DIST CLAV LK PL L 109MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 16HM00483 00885556042120

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R CAT #: 73824012LOT #: 17CM17980| CAT #: 73824014LOT #: 11HM03402| CAT #: 73824014LOT #: 16EM21773| CAT #: 73824014LOT #: 17BM09014| CAT #: UNK (4)LOT #: UNK (4 )