BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERC INSERT KIT FOR 3.0 MM KNOTLESS ST

    MDR report key: 19558633 · Received June 18, 2024

    Report

    Report Number
    1220246-2024-05925
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    March 3, 2023
    Report Date
    June 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867271647
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 IS ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT; HOWEVER, DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1938PK PERC INSERT KIT HAD A DRILL BIT THAT WAS JAMMED IN THE DRILL SLEEVE. THIS OCCURRED ON (B)(6) 2023 AT AN UNSPECIFIED TIME WITHOUT ANY CASE INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316521 PERC INSERT KIT FOR 3.0 MM KNOTLESS ST MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. PERC INSERT KIT FOR 3.0 MM KNOTLESS ST 14968578 00888867271647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown