MAUDE Adverse Event Report: ARTHREX, INC. 3.5MM DRILL, CANNULATED, REUSABLE; DRILL BIT

Model Number	3.5MM DRILL, CANNULATED, REUSABLE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Osteolysis (2377); Low Oxygen Saturation (2477)
Date of Event	07/19/2024
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
It was reported that during surgery the drill bit caused significant heating when used and caused major osteolysis which lead to surgical revision.No further information was provided.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Update ave 23-aug-2024.It was further reported that the patient was treated with arthrodesis of the carpus during the revision surgery.No further information has been provided.
Additional Manufacturer Narrative
Additional information: b5, g3, 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 a patient-specific event.

• Brand Name: 3.5MM DRILL, 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: 19966143
• Report Number: 1220246-2024-07149
• Device Sequence Number: 8856530
• Product Code: HTW
• UDI-Device Identifier: 00888867263932
• UDI-Public: 00888867263932
• 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,Followup
• Report Date (Section B): 07/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3.5MM DRILL, CANNULATED, REUSABLE
• Device Catalogue Number: AR-1530C-35-RU
• Device Lot Number: 031732
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 06/10/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/24/2024; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown