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

Model Number	T15 HEXALOBE, ISO, CANN.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 sems that an ar-8750-03 t15 hexalobe compression screw broke during an ankle arthrodesis procedure.The screw was being tightened on the handle and the tip of the screwdriver broke off inside the head of the screw.All pieces were removed and placed in a biohazard bag.An x-ray was obtained to make sure no metal pieces were left behind.The procedure was completed with no issues.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the tip of the device is broken off.The broken piece was not returned for investigation.Cause is not determined.

• Brand Name: T15 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: 16494399
• Report Number: 1220246-2023-06392
• Device Sequence Number: 15087043
• Product Code: LXH
• UDI-Device Identifier: 00888867263765
• UDI-Public: 00888867263765
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 05/04/2023

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
• Device Lot Number: 011923
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown