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	04/05/2024
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
It was reported that during a reverse shoulder surgery when using the devices ar-9216-4 (lot: 022220) and ar-9617 (lot: 022225) in combination debris was produced from the ar-9216-4.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 08-apr-2024.It was confirmed that the error occurred while working in the patient, but no debris fell into the patient and therefore nothing had to be retrieved from the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-9216-4 /batch 022220, glenoid reamer/drill glove protector, was received for evaluation.Upon visual evaluation it was noted that there were grinding marks along the inner diameter 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: 19203638
• Report Number: 1220246-2024-02567
• Device Sequence Number: 12734571
• Product Code: LXH
• UDI-Device Identifier: 00888867192638
• UDI-Public: 00888867192638
• 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,Followup
• Report Date (Section B): 09/03/2024

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
• Device Lot Number: 022220
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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