BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON, 6.0 X 260MM, 40°

    MDR report key: 24405293 · Received February 20, 2026

    Report

    Report Number
    1220246-2026-00715
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    04049197515696
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3, H3, H6. THE REPORTED EVENT WAS NOT CONFIRMED. ONE UNPACKAGED AR-S7440-060-260, KERRISON, 6.0 X 260MM, 40°, BATCH NUMBER 01577552R, WAS RECEIVED FOR INVESTIGATION AND UPON VISUAL INSPECTION, NO METAL ABRASION COULD BE OBSERVED. HOWEVER, SMALL SCRATCHES WERE FOUND IN THE CERAMIC COATING AT THE SHAFT AND AT THE DISTAL END. NO FRAGMENTS WERE RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO NORMAL WEAR AND TEAR RESULTING FROM REPETITIVE USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY BLACK METAL ABRASION WAS PRODUCED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

    Description of Event or Problem · 0

    UPDATE 02-MAR-26: FURTHER INFORMATION WAS RECEIVED ON 23-FEB-26 THAT NO PARTS REMAINED INSIDE THE PATIENT. A SPINAL DISC SURGERY WAS PERFORMED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM THE SET. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150410 KERRISON, 6.0 X 260MM, 40° SURGICAL PUNCH LXH ARTHREX, INC. KERRISON, 6.0 X 260MM, 40° 01577552R 04049197515696

    Patients

    Seq Age Sex Outcome Treatment
    1