MAUDE Adverse Event Report: ARTHREX, INC. BURR ATTACHMENT 2.35 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	BURR ATTACHMENT 2.35 MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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 (b)(6) 2025, it was reported by a sales representative via sems-07159800 that an ar-300b burr adapter is having difficulty accepting burrs.Noticed during a case, device swapped, and case completed with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Findings: dark brown debris found throughout attachment, driveshafts and seals affected.Scratches/dents found on housing and sheath doesn't affect performance.Corrective measures: attachment needs complete cleaning.Affected parts need to be replaced, load and final test.See vendor evaluation.

• Brand Name: BURR ATTACHMENT 2.35 MM
• 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: 24001837
• Report Number: 1220246-2026-00085
• Device Sequence Number: 16082714
• Product Code: LXH
• UDI-Device Identifier: 00888867099968
• UDI-Public: (01)00888867099968(11)220810(10)14990336
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: BURR ATTACHMENT 2.35 MM
• Device Catalogue Number: AR-300B
• Device Lot Number: 14990336
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown