MAUDE Adverse Event Report: ARTHREX, INC. OBTURATOR - FOR AR-6560 AND AR-6562; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OBTURATOR - FOR AR-6560 AND AR-6562
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction

• Brand Name: OBTURATOR - FOR AR-6560 AND AR-6562
• 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: 25812895
• Report Number: 1220246-2026-03777
• Device Sequence Number: 16102594
• Product Code: LXH
• UDI-Device Identifier: 00888867402775
• UDI-Public: 00888867402775
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 07/14/2026

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: OBTURATOR - FOR AR-6560 AND AR-6562
• Device Catalogue Number: AR-6563Q
• Device Lot Number: 01072516
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/14/2026
• 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