MAUDE Adverse Event Report: ARTHREX, INC. T25 HEXALOBE, ISO, CANN.; ORTHOPEDIC MANUAL SURG INSTR

Model Number	T25 HEXALOBE, ISO, CANN.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 28th october 2025, it was reported by an arthrex employee via email that an ar-8770-01, driver shaft, t25 hexalobe, cannulated, iso, trilobe, broke.The screwdriver was loaded correctly into the hand piece, and the screw was attached correctly to the screwdriver tip.Minimal force was used when the tip of the screwdriver broke off.This was detected during a calcaneal osteotomy and medial shift procedure on (b)(6) 2025.The procedure was completed successfully as a secondary screwdriver was used from the tray.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence showing an ar-8770-01 hexalobe with damage at the distal tip.Based on the information available ¿ which may include the returned device (if applicable), photographs, videos, event description, and supplemental field input ¿ arthrex has determined that the most likely cause of the reported issue is use-related factors, including: off-axis insertion during use improper or insufficient bone preparation use of the instrument for prying or leveraging with excessive force these actions can generate bending stress, torsional overload, or point-loading conditions that are consistent with the damage observed at the tip.Per dfu-0023-eo revision 5, section i.Cautions: 2.¿to avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.¿ 6.¿flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument.¿ 7.¿do not overstress the device or use the device to pry tissue.¿.

• Brand Name: T25 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: 23440118
• Report Number: 1220246-2025-04944
• Device Sequence Number: 8672267
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: 00888867263789
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: T25 HEXALOBE, ISO, CANN.
• Device Catalogue Number: AR-8770-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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