MAUDE Adverse Event Report: ARTHREX, INC. CORACOID DRILL GUIDE, SHALLOW JAW; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CORACOID DRILL GUIDE, SHALLOW JAW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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) 2024, it was reported by an arthrex subsidiary employee via sems (b)(4) that an ar-7000-17 coracoid drill guides was experiencing a failure in the trigger welding.This occurred during a case with no effect on the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image supplied from the field, a gap seems to be present on the device's welding.Additionally, signs of wear, such as dings and discoloration, are evident on the device's body.Consequently, arthrex was able to determine a most likely cause.The most likely cause of the reported failure is wear and tear.The device will inevitably sustain damage over time due to continuous mechanical forces.The manufacturing date is february 2023.

• Brand Name: CORACOID DRILL GUIDE, SHALLOW JAW
• Common Device Name: ORTHOPEDIC MANUAL SURG 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: 18987773
• Report Number: 1220246-2024-01682
• Device Sequence Number: 20891043
• Product Code: NBH
• UDI-Device Identifier: 00888867040939
• UDI-Public: 00888867040939
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: CORACOID DRILL GUIDE, SHALLOW JAW
• Device Catalogue Number: AR-7000-17
• Device Lot Number: 45552305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown