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	Insufficient Information (4580)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2024 it was reported by field staff via email that an ar-8967d drv,3.5mm hex,cann (mini hudson) snapped at the tip during use.This occurred on (b)(6) 2024 in (b)(6) hospital during a sub talar fusion.The case was completed successfully via the use of another driver.There was patient/case involvement.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection revealed the tip of the driver is completely broken off.Functional testing could not be performed due to the damage to the device.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: 19319793
• Report Number: 1220246-2024-03306
• Device Sequence Number: 20727209
• Product Code: LXH
• UDI-Device Identifier: 00888867056718
• UDI-Public: 00888867056718
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/11/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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