MAUDE Adverse Event Report: ARTHREX, INC. DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/24/2025, it was reported by a sales representative via (b)(4) that an ar-3638dhc-2 hip fibertak drill bit tip snapped off in the patient's acetabulum.15 min delay on the case.Metal was retrieved.This occurred during use in a case.
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 prying/leveraging the device during use.Dfu-0023-eo: do not overstress the device or use device to pry tissue.The complaint allegation could not be confirmed as the device was not received for investigation.

• Brand Name: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• 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: 22776252
• Report Number: 1220246-2025-03416
• Device Sequence Number: 18538093
• Product Code: LXH
• UDI-Device Identifier: 00888867430044
• UDI-Public: 00888867430044
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• Device Catalogue Number: AR-3638DHC-2
• Device Lot Number: 15418341
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown