MAUDE Adverse Event Report: ARTHREX, INC. SAW ATTACHMENT - RECIPROCATING; POWERED SURG ORTHOPEDIC INSTR

Model Number	SAW ATTACHMENT - RECIPROCATING
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2025
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
On 08/05/2025, it was reported by a distributor via (b)(4) that an ar-300sr saw attachment reciprocating was not working properly, it gets stuck.This occurred during a mini cfs system case that was completed using another device.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the saw attachment with signs of wear.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure appears to be progressive wear from repeated use in the field, which may have allowed debris particles to accumulate inside the attachment feature.This buildup could have restricted movement, causing the component to become stuck.Manufacturing date 2023.

• Brand Name: SAW ATTACHMENT - RECIPROCATING
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 22853118
• Report Number: 1220246-2025-03565
• Device Sequence Number: 4350238
• Product Code: HWE
• UDI-Device Identifier: 00888867100268
• UDI-Public: (01)00888867100268(11)231117(10)15169422
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 12/05/2025

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: SAW ATTACHMENT - RECIPROCATING
• Device Catalogue Number: AR-300SR
• Device Lot Number: 15169422
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown