BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCANEAL FRAC PERIMETER PLT,L,RT

    MDR report key: 19257953 · Received May 7, 2024

    Report

    Report Number
    1220246-2024-02869
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    September 9, 2022
    Report Date
    May 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K052614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 09/09/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN UNKNOWN PART NUMBER CALCANEAL PERIMETER PLATE'S LOCKING SCREW WENT THROUGH THE PLATE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. THE DOCTOR MENTIONED THIS HAD HAPPENED A FEW MONTHS AGO. AN ATTEMPT WAS MADE TO TAKE THE SCREW OUT, BUT IT WOULDN¿T COME OUT OF THE PLATE. SURGEON OPTED TO KEEP IT IN THE PATIENT AS IT WAS NOT PROMINENT AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440429 CALCANEAL FRAC PERIMETER PLT,L,RT BONE FIXATION PLATE HRS ARTHREX, INC. CALCANEAL FRAC PERIMETER PLT,L,RT 95241410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown