BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SAW SPORTS 400

    MDR report key: 20556280 · Received October 29, 2024

    Report

    Report Number
    1220246-2024-08292
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 20, 2024
    Report Date
    August 23, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867223318
    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 THE DRIVER IS BROKEN OFF. AR-400: THE DRIVER OF THE AR-400 IS BROKEN. THIS KNOWN ISSUE HAS ALREADY BEEN RESOLVED WITH AN APPROPRIATE CORRECTIVE MEASURE. THE DRIVER WAS REINFORCED WITH A RING (ASSEMBLY 775770, INDEX 00). AR-400SAG: THE ATTACHMENT WAS DISASSEMBLED TO ALLOW FOR A MORE DETAILED ANALYSIS. THE CAUSE OF THE FAILURE OF THE SAW ATTACHMENT IS A BROKEN CLAW (PART 5).

    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, (B)(6) 2024. RECEIVE FURTHER INFORMATION. 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, (B)(6) 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
    1197311 DRILL SAW SPORTS 400 POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. DRILL SAW SPORTS 400 15211910 00888867223318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown