MAUDE Adverse Event Report: ARTHREX, INC. T15 HEXALOBE, ISO, CANN.; ORTHOPEDIC MANUAL SURG INSTR

Model Number	T15 HEXALOBE, ISO, CANN.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/23/2025, an fda medwatch notification was received via email.A facility representative reported that an ar-8750-03 t15 hexalobe driver shaft broke while being used on a patient.All broken pieces were accounted for, and no harm was caused to the patient.Intraoperative x-ray imaging was used during the procedure to confirm that all fragments of the broken screwdriver were successfully removed.The incident occurred on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 11/4/2025: this issue was discovered during a hardware removal procedure.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was received on 11/25/2025: the issue occurred during the removal of hardware from the left ankle and calcaneus, combined with a subtalar fusion procedure.There was no case delay, and no additional anesthesia was required.Additional information was received on 12/08/2025: the hardware removal was an elective procedure performed to address pain and joint instability.The patient reported the initial onset of symptoms in (b)(6) 2024.Additional information was received on 12/15/2025: the original procedure was performed on (b)(6) 2024 and included implantation of the following arthrex devices: ar-8750-50h 5.0 large compression ft screw (50 mm length) and ar-8750-48h 5.0 large compression ft screw (48 mm length).Details regarding the arthrex part numbers explanted and implanted during the hardware removal procedure are currently unavailable.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The device was not received for evaluation.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 concluded the most likely cause.The most likely cause of the reported failure is user error, specifically using a device that may be damaged by wear and tear, with a manufacturing date of 2019.Directions for use dfu-0023-eo revision 5- instruments c.Validation repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to repeated use and/or reprocessing.The user assumes liability and is responsible for the use of a damaged or dirty device.The complaint allegation could not be confirmed because the device was not returned for evaluation, and no supporting evidence of the reported failure was provided.

• Brand Name: T15 HEXALOBE, ISO, CANN.
• 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: 23438026
• Report Number: 1220246-2025-04932
• Device Sequence Number: 4733446
• Product Code: LXH
• UDI-Device Identifier: 00888867263765
• UDI-Public: 00888867263765
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/25/2026

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: T15 HEXALOBE, ISO, CANN.
• Device Catalogue Number: AR-8750-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided; 11/25/2025; 02/23/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/24/2025; 12/23/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown