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	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the submitted radiographic photographic evidence, which shows fragments from the ar-7000-14 drill, 2.75 mm, batch 022451, remaining in the patient, consistent with the reported drill breakage during the procedure.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to misuse due to one or more of the following use-related factors: improper bone preparation, misaligned insertion, or prying or leveraging the device with excessive force during insertion, any of which could subject the drill to mechanical overstress, leading to fracture.
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 the latarjet surgery, the screws were difficult to insert because the drill was not drilling the holes properly.The following day, an x-ray of the patient revealed that a piece of the drill had broken off and was still lodged inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.03-dec-2025 majung - further information received from arthrex es: the patient is experiencing no discomfort.The fragments visible around the screw in the x-rays were caused by the drill.

• 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: 23771180
• Report Number: 1220246-2025-05565
• Device Sequence Number: 18799514
• Product Code: MDM
• UDI-Device Identifier: 00888867040908
• UDI-Public: (01)00888867040908(11)250307(10)022451
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 022451
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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