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

Model Number	T25 HEXALOBE, ISO, CANN.
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
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) 2022, it was reported by a sales representative via sems that an ar-8770-01 driver shaft, t25 hexalobe, cannulated had an issue, the tip of the driver shaft broke off.This occurred during an ankle fusion procedure on (b)(6) 2022.No piece broke off inside the patient, the device broke during use, there was no harm, and the procedure was completed successfully.This was discovered during use with no impact to the patient.Additional information was requested.On (b)(6) 2022, the sales representative stated the following information over the phone: when the tip of the driver shaft broke off, it did break off inside the patient, but all fragments were removed.
Additional Manufacturer Narrative
Additional information: d9, g3, h6 since the complaint device was not returned, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos provided.The most likely cause of this failure is attributed to wear and tear damage incurred through repeated usage.

• Brand Name: T25 HEXALOBE, ISO, CANN.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16173466
• Report Number: 1220246-2023-06123
• Device Sequence Number: 4370045
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: 00888867263789
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/24/2024

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: 011950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown