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 Codes	Defective Device (2588); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
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 (b)(6) 2024, a sales representative reported via (b)(4) that an ar-9216-4 glenoid reamer/drill glove protector blue sleeve was worn down enough over time that it no longer stays on the driveshaft and just slides off.No adverse effects on the patient were reported.The second blue sleeve in the tray was used, and the case was completely without incident.This was discovered during an rtsa procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9216-4 batch 031501 device was received for evaluation.The returned glove protector drill was visually inspected, revealing scratches on the inner diameter.There were also visible scratches and gouges on the material.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Per dfu-0023.Revision 3 c.Validation.Repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to the intended use.

• 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: 20678199
• Report Number: 1220246-2024-08519
• Device Sequence Number: 8395391
• Product Code: LXH
• UDI-Device Identifier: 00888867192638
• UDI-Public: (01)00888867192638(10)031501
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: 031501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown