MAUDE Adverse Event Report: ARTHREX, INC. DISP. CURVED KIT KNOTLESS HIP FTAK 1.8MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISP. CURVED KIT KNOTLESS HIP FTAK 1.8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/14/2025, it was reported by a sales representative via (b)(4) that an ar-3638dhc-1 disp.Curved kit knotless hip ftka drill bit broke off in bone.The broken fragment was retrieved.This was discovered during the case with no patient harm.
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.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause for the reported failure can be attributed to using excessive force or prying/leveraging the device during use.The complaint allegation was confirmed based on the customer's attached picture, which showed the tip of the drill broken off.

• Brand Name: DISP. CURVED KIT KNOTLESS HIP FTAK 1.8MM
• 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: 21944958
• Report Number: 1220246-2025-01840
• Device Sequence Number: 8382264
• Product Code: LXH
• UDI-Device Identifier: 00888867430037
• UDI-Public: (01)00888867430037(11)240325(17)290228(10)15224881
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/19/2025

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 1.8MM
• Device Catalogue Number: AR-3638DHC-1
• Device Lot Number: 15224881
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown