MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE REAMER SHAFT, 369 MM

Model Number	FLEXIBLE REAMER SHAFT, 369 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 07/01/2025, a facility representative reported via (b)(4) that an ar-9091-20 369 mm flexible reamer shaft was cold-welded onto the hudson adapter.This was discovered during a case with no adverse effects on the patient.

• Brand Name: FLEXIBLE REAMER SHAFT, 369 MM
• Common Device Name: REAMER
• 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: 22576794
• Report Number: 1220246-2025-03026
• Device Sequence Number: 9637696
• Product Code: HTO
• UDI-Device Identifier: 00888867330986
• UDI-Public: (01)00888867330986(11)210105(10)492052
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 07/23/2025

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: FLEXIBLE REAMER SHAFT, 369 MM
• Device Catalogue Number: AR-9091-20
• Device Lot Number: 492052
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown