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	10/21/2024
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 an ankle fusion plating surgery the screw driver tip broke off.The broken piece was retrieved out of the patient.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
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-8967d / batch 011743 was received for investigation.Upon visual inspection, it was noted that the drive geometry of the distal end of the driver, 3.5 mm hex, cannulated (mini hudson) was broken.No fragments were returned for evaluation.Functional testing was not performed due to the damage to the device.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly torquing/engaging the driver within the screw head and extended use in the field.Manufacturing date 2017.

• 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: 20599781
• Report Number: 1220246-2024-08384
• Device Sequence Number: 18342200
• Product Code: LXH
• UDI-Device Identifier: 00888867056718
• UDI-Public: (01)00888867056718(11)171102(10)011743
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/29/2025

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: 011743
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• 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
• Patient Sex: Unknown