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	Insufficient Information (4580)
Date of Event	02/28/2025
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
It was reported that during an ucl stabilization surgery the drill broke into two pieces.The reported issue was initially identified during the incoming inspection at the arthrex warehouse.Further information were requested and the customer confirmed that the reported issue has occurred during a surgery but did not forward a complaint as the surgery could be finished successfully.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-7720-2.0 humeral drill, 2.0 mm batch number: 021543 was received for investigation.Visual evaluation of the returned device noted the tip of the device had broken off and the broken fragment was retrieved and returned.Functional testing was not performed due to the damage to the device.The cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 05-dec-2015.Refer to investigation photos.

• 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: jared engle ; 8009337001
• MDR Report Key: 21651682
• Report Number: 1220246-2025-01046
• Device Sequence Number: 15780121
• Product Code: HTW
• UDI-Device Identifier: 00888867042124
• UDI-Public: (01)00888867042124(10)021543
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 07/01/2025

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: HUMERAL DRILL, 2.0 MM
• Device Catalogue Number: AR-7720-2.0
• Device Lot Number: 021543
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown