MAUDE Adverse Event Report: ARTHREX, INC. NAUTILUS REAMER/DRILL GLOVE PROTECTOR; MANUAL INSTR, GENERAL SURGICAL

Model Number	NAUTILUS REAMER/DRILL GLOVE PROTECTOR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder prosthesis surgery abrasion occurred, some of which remained stuck to the patient and the instrument.Nothing remained in the patient; it was rinsed out.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The reported event was confirmed as the visual evaluation of the received ar-9216-4, lot: 022412 revealed that there are striation marks and nicks along the inner diameter of the device.Also, the slot along the cannulation length is bent.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: NAUTILUS REAMER/DRILL GLOVE PROTECTOR
• 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: 22783245
• Report Number: 1220246-2025-03436
• Device Sequence Number: 15497882
• Product Code: LXH
• UDI-Device Identifier: 00888867192638
• UDI-Public: (01)00888867192638(11)240729(10)022412
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/12/2025

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: NAUTILUS REAMER/DRILL GLOVE PROTECTOR
• Device Catalogue Number: AR-9216-4
• Device Lot Number: 022412
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown