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

Model Number	600 SAGITTAL SAW BLADE EZ-105X19X1.27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a knee prosthesis (total knee replacement) surgery the outer teeth of the saw blades ar-600-012s (lot: 089328) broke off.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
The complaint allegation was confirmed.One unpackaged ar-600-012s, arthrex power system 600, 105 x 19 x 1.27 mm sagittal saw blade for arthrex 600, batch 089328, was received for evaluation.Upon visual inspection, a tooth was found to be broken off.Additionally, it was noted that damage, such as bends and nicks, was on the other teeth.A functional test was not performed because the mating part was not available for testing.The most likely cause of the reported failure is user error, including excessive side-loading, jamming, leveraging, and bending.Directions for use dfu-0199-eo revision 0, saw blades for arthrex 600 and arthrex 300 power systems.Improper use may damage tissue and may lead to premature wear, destruction of the instruments, and injury to the operator, patient, or other persons.B.Proper use jamming, leverage and bending of the saw blade must be avoided while in the template.Otherwise, the saw blade or template will be overheated, which leads to jamming of the saw blade or thermal necrosis, or even the risk of fracture.

• Brand Name: 600 SAGITTAL SAW BLADE EZ-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: 24344736
• Report Number: 1220246-2026-00613
• Device Sequence Number: 15953749
• Product Code: GFA
• UDI-Device Identifier: 00888867036628
• UDI-Public: (01)00888867036628(11)250524(17)300331(10)089328
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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 SAW BLADE EZ-105X19X1.27
• Device Catalogue Number: AR-600-012S
• Device Lot Number: 089328
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown