MAUDE Adverse Event Report: ARTHREX, INC. 600 SAGITTAL BLADE MIS 105X19X1.27; SAW BLADE

Model Number	600 SAGITTAL BLADE MIS 105X19X1.27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the knee prosthesis surgery that the saw blade broke.The broken pieces were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-600-312s, sagittal speed cut blade, batch 087346, was received for investigation.- visual inspection revealed that the distal end of the device was broken off, including the cutting teeth.- functional testing was not performed due to the damage to the device.- the most likely cause is misuse, which results from excessive user-applied mechanical forces or prying, which leverages the device during use.- refer to investigation photos.- complaint allegation is confirmed.

• Brand Name: 600 SAGITTAL BLADE MIS 105X19X1.27
• Common Device Name: SAW BLADE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22873224
• Report Number: 1220246-2025-03594
• Device Sequence Number: 10371158
• Product Code: GFA
• UDI-Device Identifier: 00888867110731
• UDI-Public: (01)00888867110731(11)250319(17)300228(10)087346
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 600 SAGITTAL BLADE MIS 105X19X1.27
• Device Catalogue Number: AR-600-312S
• Device Lot Number: 087346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown