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

Model Number NAUTILUS REAMER/DRILL GLOVE PROTECTOR

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  malfunction  

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 Description

On (b)(6) 2023, it was reported by a sales representative via sems (b)(4) that an ar-5410-01 vip glenoid reamer, pilot sharp edge on the butt of the calibrated portion caused damage to the ar-9216-4 drill glove protector by leaving bits of plastic shavings in the patient's shoulder wound.The case was completed successfully by retrieving the pieces left in the patient.This was discovered during a reverse total shoulder arthroplasty procedure on (b)(6) 2023.Product checklist was updated and additional information received on (b)(6) 2023: there was a unspecified amount of delay when removing all the fragments from the patient and no additional anesthesia was administered.There was no report of the patient experiencing adverse effects from this event.

• Brand Name: NAUTILUS REAMER/DRILL GLOVE PROTECTOR
• Type of Device: 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: 18047419
• MDR Text Key: 327065700
• Report Number: 1220246-2023-08490
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867192638
• UDI-Public: 00888867192638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NAUTILUS REAMER/DRILL GLOVE PROTECTOR
• Device Catalogue Number: AR-9216-4
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1