BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM X 18MM LOCKING CORTICAL PEG

    MDR report key: 15075652 · Received July 21, 2022

    Report

    Report Number
    3025141-2022-00231
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 21, 2022
    Report Date
    August 2, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    PMA / PMN Number
    K120903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE 2.3MM X 18MM LOCKING CORTICAL PEG PART NUMBER CO-S2318-S WAS RETURNED FOR EVALUATION. THE PART WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE PEG EXHIBITED STRIPPING IN THE BOTTOM 2-3 THREADS BELOW THE HEAD, AND THE THREADS WERE WHITE WITHOUT THE ANODIZATION COATING. THE HEAD AND HEX RECESS WERE INTACT WITH MINIMAL SIGNS OF WEAR. NO METAL SHAVINGS WERE SEEN STICKING OUT ON THE PART. THE 2.3MM X 20MM LOCKING CORTICAL PEG PART NUMBER CO-S2320-S (REPORT NUMBER 3025141-2022-00232) WAS ALSO RETURNED FOR EVALUATION. THE PEG EXHIBITED STRIPPING IN THE BOTTOM 2-3 THREADS BELOW THE HEAD, AND THE THREADS WERE WHITE WITHOUT THE ANODIZATION COATING. NO METAL SHAVINGS WERE SEEN STICKING OUT ON THE PART. THE PLATE INVOLVED IN THIS EVENT (REPORT NUMBER 3025141-2022-00233) WAS NOT RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS CONDUCTED. THE RETURNED LOCKING CORTICAL PEGS WERE INSERTED INTO THE DISTAL HOLES OF A TEST STANDARD ACU-LOC 2 VDR PLATE. ONE OF THE PEGS SCREWED IN EASILY WITH GENTLE MANUAL ROTATION. THE OTHER WOULD CATCH SLIGHTLY IN THE THREADED PORTION, BUT EVENTUALLY BE FULLY THREADED INTO THE HOLE. FOR THE REPORTED EVENT, THE EXACT METHOD OF INSERTION IS UNKNOWN. IF THE PEG WAS INSERTED OFF-AXIS FROM THE THREADED HOLES, THE THREADS COULD CATCH, AND THE PEG WOULD NOT BE ABLE TO FULLY SEAT. FOR PROXIMAL SCREW PLACEMENT, THE SURGICAL TECHNIQUE SAYS TO USE THE TARGETING GUIDE AND 2.0 MM DRILL GUIDE TO DRILL A HOLE WITH THE 2.0 MM DRILL. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN INSERTING THE LOCKING SCREW, THE SCREW DID NOT FULLY SEAT INTO THE PLATE, AND A PIECE OF METAL EMERGED FROM THE SCREW. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2022-00232 AND 3025141-2022-00233 FOR THE OTHER DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261818 2.3MM X 18MM LOCKING CORTICAL PEG ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC CO-S2318-S 540741

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown