MAUDE Adverse Event Report: ARTHREX, INC. 1.9MM FLEXIBLE DRILL HIP FTAK, FLUTED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	1.9MM FLEXIBLE DRILL HIP FTAK, FLUTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/17/2025, it was reported by a sales representative via phone that (4) ar-3636h self bunching 1.8 knotless hip fibertaks failed, an ar-3600nd-4hf disposable flexible fluted drill broke, and an ar-6527-19 hook knife broke.This occurred during a hip arthroscopy on 03/14/2025 the first anchor did not hold in the bone and the the inserter was bent.The second one backed out of the bone, the third ones suture was frayed and was not used.The fourth one was placed in the bone and then when converting the suture the tensioning broke.The implant remained in the patient.They switched to an ar-3600nd-4hf drill which broke.All fragments were retrieved.They proceeded with standard pushlocks.The ar-6527-19 15244183 bent and broke.All fragments were retrieved.
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 improper bone preparation, misalignment, prying/leveraging, and/or excessive force used during suture passing/tightening /tensioning.

• Brand Name: 1.9MM FLEXIBLE DRILL HIP FTAK, FLUTED
• 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: 21773529
• Report Number: 1220246-2025-01229
• Device Sequence Number: 9748723
• Product Code: LXH
• UDI-Device Identifier: 00888867430020
• UDI-Public: (01)00888867430020(11)240515(17)290430(10)15248883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/04/2025

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: 1.9MM FLEXIBLE DRILL HIP FTAK, FLUTED
• Device Catalogue Number: AR-3600ND-4HF
• Device Lot Number: 15248883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown