BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURELASSO, 45 DEGREE, CURVE LEFT

    MDR report key: 19738906 · Received July 15, 2024

    Report

    Report Number
    1220246-2024-06729
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 17, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867031470
    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

    COMPLAINT ALLEGATION WAS NOT CONFIRMED. TWO SEALED PACKAGES OF AR-4068-45L WITH THE BATCH NUMBER 4003137529 WERE RECEIVED FOR EVALUATION. HOWEVER, THE DEVICES IN QUESTION FOR THE COMPLAINT ALLEGATION WERE NOT RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND NOT ISSUES WITH THE RETURNED DEVICES. THE OUTER TUBE DIAMETER WAS MEASURE BY DRAWING C4323 AT REVISION. 1. Ø .153 ± .001. RESULTS. .153 THE CURVED TIP WAS MEASURED BY DRAWING C4313 AT REVISION 0. Ø .073 ± .001 RESULT. .073. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO, MISALIGNED INSERTION, PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE TIP OF THE DEVICE BROKE OFF WHEN PIERCING THE TISSUE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. 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
    1460044 SUTURELASSO, 45 DEGREE, CURVE LEFT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. SUTURELASSO, 45 DEGREE, CURVE LEFT 4003137529 00888867031470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown