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	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that ar-9617 drive shaft ar-9216-4 reamer/drill glove protector produces metal shaving when connected and in use.This was discovered during a procedure.Additional information received on 7/13/2023: this was discovered during an eclipse primary total shoulder procedure on (b)(6) 2023.The debris was produced on the back table and not while reaming inside of the patient.Different sleeves and drivers were tired multiple times.But each blue sleeve continued to drop shavings on the back table.The sleeves and drivers were switched out to a different set, and the case was completed without further issues.The exact part numbers for the new set are unknown.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.Two unpackaged ar-9216-4, serial/batch number (b)(6), were received for investigation.Upon visual evaluation, it was found that the slot was damaged in both devices.A slot dimension check with a pin gauge.04 pass through the slot was not possible because the slot was too narrow/damaged.The device material shrank.It was noted that there were flash and scratches inside the devices.The most likely cause for the reported failure is a user error.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17458157
• Report Number: 1220246-2023-07418
• Device Sequence Number: 15251304
• Product Code: LXH
• UDI-Device Identifier: 00888867192638
• UDI-Public: 00888867192638
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 11/04/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 11/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown