MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL DRILL, 2.0 MM; DRILL BIT

Model Number	HUMERAL DRILL, 2.0 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023 , by a facility representative via sems that an ar-7720-2.0 humeral drill broke.Case involvement, device breaks during use.Per facility: "the arthrex articulating guide for the 2.5 mm drill was then positioned and 2 drill holes were connected with the 15 mm tunnel to create a y configuration for docking.The tendon and allowing passing sutures to be tied over a bone bridge.Of note, during drilling of one of the 2.5 mm tunnels, the drill bit broke in bone.The drill bit was successfully removed with a hemostat and the mini c-arm was brought in to confirm the removal of the metal bit.There was no suitable backup drill bit in the arthrex set so a 2 mm drill bit was opened from another set and used to redrill through the guide to the backstop to complete the anterior y connecting tunnel.".
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.
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 misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: HUMERAL DRILL, 2.0 MM
• Common Device Name: DRILL BIT
• 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: 16751785
• Report Number: 1220246-2023-06539
• Device Sequence Number: 8556583
• Product Code: HTW
• UDI-Device Identifier: 00888867042124
• UDI-Public: 00888867042124
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: HUMERAL DRILL, 2.0 MM
• Device Catalogue Number: AR-7720-2.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown