BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW ATTACHMENT-SAGITTAL

    MDR report key: 20842621 · Received December 4, 2024

    Report

    Report Number
    1220246-2024-08688
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 6, 2024
    Report Date
    August 22, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867111073
    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: D9, G3, H3, H6. THE MANUFACTURER EVALUATION REVEALED A LOOSE SCREW 483850 WHICH RESULTED IN THE REPORTED EVENT. FURTHER EVALUATION DID NOT REVEAL ANY DAMAGES AT THE THREAD OF THE SCREW AND LOCTITE IS ALSO VISIBLE. THE REPORTED EVENT THEREFORE IS CONFIRMED. IF THE SCREW IS EXPOSED TO STRONG VIBRATION, IT CAN LEAD TO LOOSENING OF THE SCREW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAW ATTACHMENT IS DEFECTIVE, THE SAW BLADE DOES NOT HOLD IN THE ANCHORAGE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE, KHE, 26-NOV-2026 FURTHER INFORMATION RECEIVED WITH A COMPLAINT FORM. THE EVENT OCCURRED DURING A SHOULDER PROSTHESIS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO PIECE BROKE OFF INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NO. 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
    1681444 SAW ATTACHMENT-SAGITTAL POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. SAW ATTACHMENT-SAGITTAL 15088994 00888867111073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown