MAUDE Adverse Event Report: ARTHREX, INC. VIP¿ GLENOID REAMER, PILOT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	VIP¿ GLENOID REAMER, PILOT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
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 sems-06049844 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 10/24/2023: 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to excessive force/friction during use or insertion and/or prying/leveraging the devices during use.

• Brand Name: VIP¿ GLENOID REAMER, PILOT
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 18037781
• Report Number: 1220246-2023-08459
• Device Sequence Number: 7259744
• Product Code: KWS
• UDI-Device Identifier: 00888867392250
• UDI-Public: 00888867392250
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222007
• 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): 03/11/2025

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: VIP¿ GLENOID REAMER, PILOT
• Device Catalogue Number: AR-5410-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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