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

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	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/13/2025, it was reported by a sales representative via (b)(4).That an ar-3600nd-4hf 1.9mm flexible drill hip tip broke off inside the patient's acetabulum while the bone was being drilled.This was discovered during a hip labral repair and was completed 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 allegation is confirmed based on photographic evidence of an ar-3600nd-4hf, batch 15486073, with a damaged distal end.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is user-related, such as off-axis insertion, improper bone preparation, or prying or leveraging the device with excessive force.

• Brand Name: 1.9MM FLEXIBLE DRILL HIP FTAK, FLUTED
• 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: 23704551
• Report Number: 1220246-2025-05343
• Device Sequence Number: 10670687
• Product Code: LXH
• UDI-Device Identifier: 00888867430020
• UDI-Public: (01)00888867430020(11)250821(17)300731(10)15486073
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/18/2026

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: 1.9MM FLEXIBLE DRILL HIP FTAK, FLUTED
• Device Catalogue Number: AR-3600ND-4HF
• Device Lot Number: 15486073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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