BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW ATTACHMENT-SAGITTAL

    MDR report key: 20556271 · Received October 29, 2024

    Report

    Report Number
    1220246-2024-08291
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 20, 2024
    Report Date
    September 16, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867223424
    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: D9, G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED. THE MANUFACTURER EVALUATION REVEALED A BROKEN CLAW AT THE TOOL CONNECTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. 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 USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION. THE REPORTED EVENT WAS CONFIRMED. THE MANUFACTURER EVALUATION REVEALED A BROKEN CLAW AT THE TOOL CONNECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOTH DEVICES ARE DEFECTIVE AND THEY WOBBLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. ***UPDATE, KHE, 11-OCT-2024 FURTHER INFORMATION RECEIVED. IT WAS REPORTED THAT THE MACHINE RUNS IRREGULARLY FROM THE SAW BLADE DURING USE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. ***UPDATE, KHE, 15-OCT-2024 FURTHER INFORMATION RECEIVED. THE EVENT OCCURRED DURING A REPOSITIONING OSTEOTOMY FEMUR. NO PIECE BROKE OFF INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE CLAIMED 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
    1197302 SAW ATTACHMENT-SAGITTAL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SAW ATTACHMENT-SAGITTAL 15222697 00888867223424

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown