MAUDE Adverse Event Report: ARTHREX, INC. DRV,3.5MM HEX,CANN (MINI HUDSON); ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRV,3.5MM HEX,CANN (MINI HUDSON)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/25/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8967d driver broke.This occurred during a surgery where no fragments remained in the patient.The procedure ended normally, using another key.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 of the device due to over-torquing/over-engaging the driver with the screw head.

• Brand Name: DRV,3.5MM HEX,CANN (MINI HUDSON)
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 20632168
• Report Number: 1220246-2024-08452
• Device Sequence Number: 20669065
• Product Code: LXH
• UDI-Device Identifier: 00888867056718
• UDI-Public: (01)00888867056718(11)190930(10)47321932
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/21/2025

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: DRV,3.5MM HEX,CANN (MINI HUDSON)
• Device Catalogue Number: AR-8967D
• Device Lot Number: 47321932
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2019
• 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