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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-300b burr's locking mechanism is not holding.Discovered during a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged, ar-300b, burr attachment 2.35 mm, batch 15249640, was received for evaluation.Visual inspection noted a broken clamping system in the drive shaft.Functional testing revealed that the device would not hold a burr in place when it was in the 'lock' position.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during insertion.Complaint allegation is confirmed.

• 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: 22309689
• Report Number: 1220246-2025-02630
• Device Sequence Number: 8082266
• Product Code: LXH
• UDI-Device Identifier: 00888867099968
• UDI-Public: (01)00888867099968(11)240516(10)15249640
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: BURR ATTACHMENT 2.35 MM
• Device Catalogue Number: AR-300B
• Device Lot Number: 15249640
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown