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 Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2025
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
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-7000-14, drill, 2.75 mm, 0.066'' cannulation, the long 2.75 mm cannulated drill tip shattered in fragments inside patient after inserting guide wires.This was detected during use in a congruent-arc latarjet procedure using the glenoid bone loss set with 3.75 mm cannulated screws on (b)(6) 2025.The procedure was completed successfully as x-rays were called in to identify and remove fragments of device inside the patient, and an alternative 2.75mm cannulated screw used in place.2 fragments unable to be retrieved in patient, but surgeons' clinical judgement was to leave as it is inside the bone and won't cause any issues with the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of a damaged ar-7000-14 drill, batch 022516, in which the distal tip appears fractured.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, the event description, and any additional field input ¿ arthrex has determined the most likely cause of the reported failure.The most likely cause is attributed to off-axis engagement and prying or leveraging of the device with excessive force during drilling, resulting in mechanical overstress and tip fracture.

• 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: 23392781
• Report Number: 1220246-2025-04843
• Device Sequence Number: 9979051
• Product Code: MDM
• UDI-Device Identifier: 00888867040908
• UDI-Public: 00888867040908
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/25/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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