MAUDE Adverse Event Report: ARTHREX, INC. 5.0MM, DRL BIT, CANNULATED, REUSABLE; DRILL BIT

Model Number	5.0MM, DRL BIT, CANNULATED, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ankle fusion surgery the device broke.All parts were retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8770-02-ru, 5.0 mm drill bit, batch 032242, was received for investigation.Upon evaluation, the device's tip and proximal end were damaged.Functional testing could not be performed due to the damage to the device.The most likely cause of the reported failure is user error, such as misaligned insertion and/or prying/leveraging the device during use.Refer to investigation photos.The complaint allegation is confirmed.

• Brand Name: 5.0MM, DRL BIT, CANNULATED, REUSABLE
• 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: 21618967
• Report Number: 1220246-2025-00968
• Device Sequence Number: 18254309
• Product Code: HTW
• UDI-Device Identifier: 00888867319592
• UDI-Public: (01)00888867319592(11)221031(10)032242
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/06/2025

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: 5.0MM, DRL BIT, CANNULATED, REUSABLE
• Device Catalogue Number: AR-8770-02-RU
• Device Lot Number: 032242
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown