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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
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
It was reported that during multiple events the customer experienced issues with the drill guide and the k-wire.The drill became stuck and pushed the guidewire further into the joint the customer was not able to provide any further information how many events with the reported event has occured.The customer reported further that the issue always with an ar-8770-02ru but the customer experienced the same issue with the ar-8770k and ar-8770kt.Per complaint reporter there was no harm for patient, operator or third party.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or prying/leveraging the device during use.

• 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: 20506820
• Report Number: 1220246-2024-08207
• Device Sequence Number: 8303913
• Product Code: HTW
• UDI-Device Identifier: 00888867319592
• UDI-Public: 00888867319592
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 08/14/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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