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	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-jan-2026, it was reported by an arthrex employee via (b)(4) that (qty.2) of an ar-7000-14 drill bit broke.It was removed and the surgeon used a new drill bit, but it broke again and was removed.The fragments remained inside the patient.This was discovered during the case.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence showing a fractured ar-7000-14 drill (2.75 mm, 0.066" cannulation), batch 022327.Additionally, an x-ray demonstrates retained drill fragments lodged within the patient.Based on the information provided ¿ which may include the returned device (if available), photographs, the event description, and any additional field input ¿ arthrex has determined the most likely cause of the reported issue involving two ar-7000-14 drill bits fracturing during use.The most likely cause is attributed to use-related factors, including misaligned insertion, prying or leveraging the drill, and excessive mechanical stress applied during drilling.These conditions can subject the drill bit to unintended side-loading or torque beyond its mechanical limits, leading to fracture.Per dfu-0023-eo, revision 4 ¿ section i.Caution2.¿to avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.¿ 3.¿do not use arthrex instruments for any purpose other than their intended use.Manipulating soft tissue or bone with an instrument not intended for that use may result in damage to the instrument.¿ these dfu cautions support that improper force application, misalignment, or off-axis loading during drilling can contribute to instrument damage and 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: 24208160
• Report Number: 1220246-2026-00337
• Device Sequence Number: 15838830
• Product Code: MDM
• UDI-Device Identifier: 00888867040908
• UDI-Public: (01)00888867040908(11)230714(10)022327
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 01/29/2026

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: 022327
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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