MAUDE Adverse Event Report: Arthrex, Inc. SAW ATTACHMENT - SAGITTAL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SAW ATTACHMENT - SAGITTAL
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a cetas healthcare notification was received via email indicating that information from a clinical study had been obtained.The report stated that the healthcare professional (hcp) reported hcp reported that overheating of attachment or connected components was observed during usage.Hcp also reported that it was a use-related or handling issue and same adverse event was experienced previously.No additional treatment was required to treat the adverse event.Device causality was assessed by the hcp as probably related to the device.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SAW ATTACHMENT - SAGITTAL
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50817093
• Report Number: 1220246-2026-04799
• Device Sequence Number: 10127542
• Product Code: HWE
• UDI-Device Identifier: 00888867100251
• UDI-Public: 00888867100251
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: SAW ATTACHMENT - SAGITTAL
• Device Catalogue Number: AR-300SAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown