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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 30-dec-2025, it was reported by a sales representative via (b)(4) that an ar-3638dhc-2 knotless hip ftak had metal shavings coming from the drill.Fragments were retrieved from the patient.This was discovered during a hip scope with no patient harm.
Additional Manufacturer Narrative
Based on the information provided ¿ which may include the device (if available and returned), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause of the reported failure is use-related factors, specifically improper drilling technique.The most likely cause is use-related generation of metallic debris from the drill during the procedure due to contact with dense bone and/or inadvertent contact with another instrument, resulting in the observed metal shavings.

• 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: 24180140
• Report Number: 1220246-2026-00326
• Device Sequence Number: 13150881
• Product Code: LXH
• UDI-Device Identifier: 00888867430044
• UDI-Public: (01)00888867430044(11)251118(17)301031(10)15532145
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 01/26/2026

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: 15532145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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