MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM FLEXIBLE DRILL HIP FTAK, FLUTED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	1.8MM FLEXIBLE DRILL HIP FTAK, FLUTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-dec-2025, it was reported by a sales representative via (b)(4) that during hip scope and labral repair, two anchors were placed into the patient.When they drilled for the third anchor, an ar-3600nd-2hf 1.8 mm flexible drill bit broke off inside and was left in the patient.The device was discarded and another device was used to complete the case without significant delay.
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 returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, including misaligned insertion and/or prying or levering the device during insertion/use, which resulted in damage to the device.The complaint allegation was confirmed based on the evaluation of the customer-provided image, which showed that part of the drill tip had broken off.

• Brand Name: 1.8MM 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: 23933875
• Report Number: 1220246-2025-05915
• Device Sequence Number: 9611241
• Product Code: LXH
• UDI-Device Identifier: 00888867430013
• UDI-Public: (01)00888867430013(11)250811(17)300731(10)15480922
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/15/2026

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: 1.8MM FLEXIBLE DRILL HIP FTAK, FLUTED
• Device Catalogue Number: AR-3600ND-2HF
• Device Lot Number: 15480922
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown