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

Model Number	3.0MM MGS DRILL BIT, STERILE
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
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 that a ar-9628s modular glenoid system 3.0 mm drill sheered off.This occurred during a reverse total shoulder replacement on (b)(6) 2023 when the drill sheered off from it's hudson adapter while drilling the glenoid.The broken fragment was retrieved, and the case was completed using a new drill.There was no patient effect reported.
Additional Manufacturer Narrative
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 of the device due to improper bone preparation, misaligned insertion and/or prying/leveraging during use.
Event or Problem Description
Additional information was provided on 02/09/2023 where it was reported by a sales representative that the patient had normal bone quality.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 16459008
• Report Number: 1220246-2023-06361
• Device Sequence Number: 6449452
• Product Code: HWE
• UDI-Device Identifier: 00888867350571
• UDI-Public: 00888867350571
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 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: 02/07/2023
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown