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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/07/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1678-05 drill bit for swivelock® broke.This occurred during use when the tip broke off while drilling the bone to place the swivelock anchor.A larger incision was made to remove the drill bit, but this did not have a negative impact.The technique used was adjusted because the patient was diabetic and the bone was very dry, with little irrigation.The procedure was completed normally, and when the drill broke, it had already performed the intended function.
Event or Problem Description
Additional information was provided on 09/01/2025 where it was reported that this event occurred during an achilles tendon rupture ¿ tendon reattachment.There was only one fragment, and the doctor was able to remove it.There was no significant delay; no additional anesthesia was necessary.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the shaft of the drill bit for swivelock®, 3.5 mm was broken off.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Dfu-0023-eo - 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.2.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.Dull devices may require replacement if they no longer perform as designed.Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly torquing/engaging/drilling process and extended use in the field.Manufacturing date 2019.

• 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: 22883132
• Report Number: 1220246-2025-03612
• Device Sequence Number: 15668807
• Product Code: HTW
• UDI-Device Identifier: 00888867020863
• UDI-Public: 00888867020863
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 4511907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown