MAUDE Adverse Event Report: ARTHREX, INC. T10 HEXALOBE, CMP FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	T10 HEXALOBE, CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
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 7/3/2025, an fda medwatch notification was received via email.A facility representative reported that two ar-8737-38 driver shaft tips broke intraoperatively while in use on a patient.All broken fragments were successfully retrieved and confirmed via clear radiographic imaging.No harm to the patient was reported.Additional information received on 7/14/2025: the patient underwent a left triple arthrodesis.The procedure was completed without any further issues, and there was no delay in surgery.No additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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.Per dfu-0023-eo e.Inspection and maintenance 1.Arthrex non-sterile devices are precision medical devices and must be used and handled with care.Inspect the devices for damage prior to use, and at all stages of handling thereafter.If damage is detected, do not use the device prior to consulting the manufacturer for guidance.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly torquing/engaging the driver within the screw head and extended use in the field.Manufacturing date 2022.

• Brand Name: T10 HEXALOBE, CMP FT
• 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: 22612465
• Report Number: 1220246-2025-03096
• Device Sequence Number: 5457588
• Product Code: LXH
• UDI-Device Identifier: 00888867127166
• UDI-Public: (01)00888867127166(11)220728(10)1392230
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: T10 HEXALOBE, CMP FT
• Device Catalogue Number: AR-8737-38
• Device Lot Number: 1392230
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown