MAUDE Adverse Event Report: ARTHREX, INC. REAMER 17MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REAMER 17MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
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 11/07/2025, it was reported by a sales representative via (b)(4) that an ar-4092hr-17 reamer was so dull it was burning the bone.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
The complaint allegation cannot be confirmed based on the image submitted for evaluation of an ar-4092hr-17 reamer.The image does not provide sufficient detail to identify a specific point of failure.Based on the information available ¿ which may include the returned device (if available), photographs, videos, the event description, and any additional field input ¿ arthrex has determined the most likely cause as follows: the reported failure is most likely attributable to user-related factors, such as prolonged or excessive force applied during reaming.Additional contributing factors may include: off-axis loading, misaligned insertion.Cumulative wear-and-tear or sustained damage in the field over time.

• Brand Name: REAMER 17MM
• Common Device Name: ORTHOPEDIC MANUAL SURG 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: 23681515
• Report Number: 1220246-2025-05273
• Device Sequence Number: 9846953
• Product Code: LXH
• UDI-Device Identifier: 00888867236684
• UDI-Public: 00888867236684
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 03/09/2026

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: REAMER 17MM
• Device Catalogue Number: AR-4092HR-17
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown