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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-8770-01 driver shaft t25 hexalobe broke inside a 7.0 headless compression screw during insertion of the screw.The broken fragments were removed from the screw, and the screw remained implanted without issue.This was discovered during a procedure.Additional information received on (b)(6) 2023: this was discovered during a subtalar fusion procedure on 11/14/2023.The hexalobe driver shaft broke inside an ar-8770-xxh screw; the size is unknown, and the screw remained implanted.The case was delayed for about five minutes, and anesthesia was administered for that time.The patient suffered no significant symptoms or negative effects on or after the surgery.
Additional Manufacturer Narrative
Additional information: complaint is confirmed.Upon visual inspection, it was noted that the drive geometry at the distal tip of the returned driver shaft, t25 hexalobe, cannulated, iso, trilobe had broken.No broken piece was returned for investigation.Functional testing was not performed due to the damaged distal tip of the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage torquing/engaging the driver within the screw head.Device manufactured in 2019.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18293072
• Report Number: 1220246-2023-09308
• Device Sequence Number: 12474365
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: 00888867263789
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/20/2024

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: 011922
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown