MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM MGS DRILL BIT, STERILE; POWERED SURG ORTHOPEDIC INSTR

Model Number	3.0MM MGS DRILL BIT, STERILE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2025
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 01/30/2025, a sales representative reported via (b)(4) that an ar-9628s univers revers¿ modular glenoid system 3.0 mm drill bit fractured.This occurred during a reverse total shoulder arthroplasty when the tip of the drill bit broke off intraoperatively.The missing portion of the drill bit has not been visually identified or verified postoperatively and is potentially retained within the patient.
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 misaligned insertion; prying/leveraging the device during use.

• Brand Name: 3.0MM MGS DRILL BIT, STERILE
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 21397871
• Report Number: 1220246-2025-00463
• Device Sequence Number: 7586682
• Product Code: HWE
• UDI-Device Identifier: 00888867350571
• UDI-Public: 00888867350571
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 3.0MM MGS DRILL BIT, STERILE
• Device Catalogue Number: AR-9628S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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