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

Model Number	ANGLED REAMER, ORIENTATION HANDLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
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 03/28/2025, it was reported by a sales representative via (b)(6) that an ar-9597-20 reamer sleeve fused into the ar-9678 orientation handle and would not spin.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged ar-9678 angled reamer orientation handle batch number: 052317 was received for investigation.Visual evaluation of the returned device noted no apparent issues with the exterior of the device.Functional testing was performed by assembling the returned device with the returned ar-9597-20 angled reamer sleeve and it was found that the ar-9678 securely locked and unlocked as intended with the ar-9597-20.No problem found.

• Brand Name: ANGLED REAMER, ORIENTATION HANDLE
• 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: 21890355
• Report Number: 1220246-2025-01661
• Device Sequence Number: 3434529
• Product Code: LXH
• UDI-Device Identifier: 00888867324947
• UDI-Public: 00888867324947
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: ANGLED REAMER, ORIENTATION HANDLE
• Device Catalogue Number: AR-9678
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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