MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT FOR 3.5MM SWIVELOCK

Model Number	DRILL BIT FOR 3.5MM SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2025
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 11th december 2025, it was reported by an arthrex employee via email that for an ar-1678-05, drill bit for swivelock®, 3.5 mm, the drill piece snapped and broke off during drilling.This was detected during use in a brostrum + internal brace procedure on (b)(6) 2025.The procedure was completed successfully as they used a needle holder to remove the drill piece.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error, including excessive force, misaligned insertion, prying or levering the device, and/or contact with another instrument during use, which resulted in breakage.Additionally, the device was manufactured in 2018; age-related wear may also have contributed to the failure.Directions for use - dfu-0023-eo revision 5 - instruments c.Validation repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to repeated use and/or reprocessing.The user assumes liability and is responsible for the use of a damaged or dirty device.E.Inspection and maintenance 1.Arthrex non-sterile devices are precision medical devices and must be used and handled with care.Inspect the devices for damage prior to use, and at all stages of handling thereafter.If damage is detected, do not use the device prior to consulting the manufacturer for guidance.I.Cautions 2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.7.Do not overstress the device or use device to pry tissue.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: DRILL BIT FOR 3.5MM SWIVELOCK
• 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: 23934191
• Report Number: 1220246-2025-05919
• Device Sequence Number: 20236496
• Product Code: HTW
• UDI-Device Identifier: 00888867020863
• UDI-Public: (01)00888867020863(11)180220(10)04511806
• 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): 03/25/2026

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 BIT FOR 3.5MM SWIVELOCK
• Device Catalogue Number: AR-1678-05
• Device Lot Number: 04511806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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