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

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	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/14/2024, it was reported by a sales representative via sems-06711998 that an ar-3638dhc-1 knotless fibertak broke off inside the patient.Broken piece was removed.Another device was opened, and it too broke off inside the patient.Broken piece was retrieved from patient.Another lot number was used, and the case was completed with no adverse effects to the patient.This occurred during use in a case with no patient effect.
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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: DISP. CURVED KIT KNOTLESS HIP FTAK 1.8MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 20916575
• Report Number: 1220246-2024-08827
• Device Sequence Number: 7958237
• Product Code: LXH
• UDI-Device Identifier: 00888867430037
• UDI-Public: (01)00888867430037(11)240222(17)290131(10)15211257
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/09/2025

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 1.8MM
• Device Catalogue Number: AR-3638DHC-1
• Device Lot Number: 15211257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• 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