MAUDE Adverse Event Report: ARTHREX, INC. VIP¿ GLENOID REAMER, AUGMENTED MGS SMALL; PROSTHESIS, SHOULDER, CEMENTED

Model Number	VIP¿ GLENOID REAMER, AUGMENTED MGS SMALL
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
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 08/28/2024, a sales representative via (b)(4) reported that (qty.2) of an ar-5410-amgs-s vip glenoid reamer had an issue during use.During the reaming of an augmented 20-degree glenoid with the depth of a small reamer ar-5410-amgs-s, the surgeon noticed the reamer was stuck with a gap while still connected to the reamer handle.When removed, it seemed stuck in one orientation rather than freely rotating.The surgeon reattached it and tried the trigger on the powered handpiece, but the reamer created that gap because it was stuck in one orientation.They attempted to use a second reamer of the same part number, but the same event occurred.After inspection of the devices, it was noted that the drive shaft and 20 augmented reamer guides were not the issue, although the two reamers had the same problem.They are both still stuck in one orientation, and it appears on the backside that connects the reamer handle with metal cut circles seem to be making contact.The case was completed by utilizing a non-depth ream augmented reamer.A case delay of two minutes was reported without adverse effects on the patient.This event was not an unplanned incision, and no second surgery was needed.This was discovered during a reverse total shoulder procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
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 misuse/mishandling due to damage to the device.

• Brand Name: VIP¿ GLENOID REAMER, AUGMENTED MGS SMALL
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 20214685
• Report Number: 1220246-2024-07619
• Device Sequence Number: 12636110
• Product Code: KWS
• UDI-Device Identifier: 00888867409743
• UDI-Public: 00888867409743
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/18/2025

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, AUGMENTED MGS SMALL
• Device Catalogue Number: AR-5410-AMGS-S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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