MAUDE Adverse Event Report: ARTHREX, INC. 2.5/1.7MM DRILL GUIDE; ARTHROSCOPIC ACCESSORIES

Model Number	2.5/1.7MM DRILL GUIDE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/06/2025, it was reported by a sales representative via (b)(4) that an ar-8916-23 drill guide has an unknown broken drill bit stuck inside it.This occurred during use in 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: d9, g3, h3, h6.Complaint allegation is not confirmed.Upon visual inspection, it was noted that the device does not have any issues.Functional testing was performed, and noted that the inner sleeve moves freely within the outer sleeve and end cap.No problem found with the device returned.

• Brand Name: 2.5/1.7MM DRILL GUIDE
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 22116691
• Report Number: 1220246-2025-02305
• Device Sequence Number: 4251112
• Product Code: NBH
• UDI-Device Identifier: 00888867130180
• UDI-Public: 00888867130180
• 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): 07/21/2025

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: 2.5/1.7MM DRILL GUIDE
• Device Catalogue Number: AR-8916-23
• Device Lot Number: 012009
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown