MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 2.75MM, .066 CANNULATION; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRILL, 2.75MM, .066 CANNULATION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 26th november 2025, it was reported by an arthrex employee via email that an ar-7000-14, drill, 2.75 mm, 0.066'' cannulation, was being used to drill into the glenoid, the drill hit a steinman pin which had previously been placed by the surgeon, causing the 2.75mm cannulated drill to break into a number of pieces.Several pieces were retrieved but some were stuck lodged in the bone tunnel.X-ray was used to confirm that all fragments were inside the bone tunnel and stable (not loose).This was detected during a latarjet procedure on (b)(6) 2025.The procedure was completed successfully as the screw was inserted into the already drilled bone tunnel where the remaining stable fragments were located.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, including the device coming into contact with another instrument during use.The complaint allegation was confirmed upon review of the customer¿s attached picture, which showed two drills, one of which appeared to be broken at the tip.

• Brand Name: DRILL, 2.75MM, .066 CANNULATION
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 23818285
• Report Number: 1220246-2025-05637
• Device Sequence Number: 13086328
• Product Code: MDM
• UDI-Device Identifier: 00888867040908
• UDI-Public: (01)00888867040908(11)250915(10)022537
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/18/2026

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: DRILL, 2.75MM, .066 CANNULATION
• Device Catalogue Number: AR-7000-14
• Device Lot Number: 022537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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