MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, .059" (1.5MM), AO

Model Number	DRILL BIT, .059" (1.5MM), AO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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 07/07/2025, a facility representative reported via (b)(4) that an ar-18800-01 drill bit was noted inside the patient.This occurred during the removal of the right foot external fixator right fourth metatarsal lengthening with allograft placement and internal fixation, extensor digitorum longus tendon lengthening right foot, fourth metatarsal phalangeal joint capsulotomy right foot, tailors bunion repair with distal fifth metatarsal osteotomy and screw fixation right foot arthrex cannulated bone dowel revision allograft when the drill bit was noted inside the incision when the final x-ray was taken.The fragment was approximately.5cm in length.The fragment was removed with no harm to the patient.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was provided on 07/17/2025 where it was stated they are usure how the device broke, possibly during drilling it may have hit the k-wire.The patient had a good bone quality.All fragments were retrieved.The procedure was complete before the broken drill bit was discovered.There was a 30 minute delay that did require additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex was able to determine the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: DRILL BIT, .059" (1.5MM), AO
• 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: 22665654
• Report Number: 1220246-2025-03149
• Device Sequence Number: 3824708
• Product Code: HTW
• UDI-Device Identifier: 00888867385504
• UDI-Public: (01)00888867385504(11)231213(10)1392349
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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, .059" (1.5MM), AO
• Device Catalogue Number: AR-18800-01
• Device Lot Number: 1392349
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 11/04/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/20/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown