MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER HEAD, S; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER HEAD, S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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 16-jan-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-9675-s small angled reamer gave way when it was positioned in the guide and they began to turn it.The surgeon was unable to perform the drilling.Then, when the surgeon checked it off the operating table, the internal pin came out.This was discovered during a procedure with no patient harm.The case was completed with another reamer in which the internal pin did not come loose.

• Brand Name: ANGLED REAMER HEAD, S
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24258860
• Report Number: 1220246-2026-00406
• Device Sequence Number: 8064952
• Product Code: LXH
• UDI-Device Identifier: 00888867324725
• UDI-Public: (01)00888867324725(11)250424(17)300331(10)15425691
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: ANGLED REAMER HEAD, S
• Device Catalogue Number: AR-9675-S
• Device Lot Number: 15425691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown