BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK

    MDR report key: 19505545 · Received June 10, 2024

    Report

    Report Number
    1220246-2024-05506
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    December 14, 2021
    Report Date
    June 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867367265
    PMA / PMN Number
    K191226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    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 IS USER ERROR FOR APPLYING EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 0

    ON 12/14/2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT THE PUNCH HANDLE, FROM AN AR-1665BCSL SWIVELOCK IMPLANT SYSTEM, SPUN AND WOULDN'T PULL OUT FROM BONE AFTER SURGEON TAPPED IT WITH A MALLET TO CREATE BONE HOLE. THIS WAS DISCOVERED DURING A PROCEDURE. SURGEON HAD TO USE PLIERS AND MALLET THE PUNCH OUT. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/15/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT THIS OCCURRED DURING AN RCR PROCEDURE. NOTHING BROKE INSIDE THE PATIENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13244 LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK 13542222 00888867367265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other