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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
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 04/30/2025, a facility representative reported via (b)(4) that an ar-300b burr attachment was stuck in the tip and won¿t come out.This happened during a case.There were no adverse effects on the patient.
Additional Manufacturer Narrative
One unpackaged ar-300b with batch number 14915243 was received for investigation.Upon visual evaluation, a drill bit was noted to be stuck inside.Additionally, the proximal end was noted to be discolored and corroded.The most likely cause is misuse due to misaligned insertion or prying/leveraging the screw during insertion.The 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: 22051135
• Report Number: 1220246-2025-02110
• Device Sequence Number: 9095956
• Product Code: LXH
• UDI-Device Identifier: 00888867099968
• UDI-Public: (01)00888867099968(11)220117(10)14915243
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 14915243
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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