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	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a subtalar arthrodesis surgery the screwdriver broke.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update dw 12-jan-2024: further information were provided that the broken fragment was retrieved out of the patient.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Functional testing was not performed on the returned ar-8770-01 due to the damage to the tip of the device.Visual evaluation was performed, and noted the driver shaft tip is broken off.The most likely cause is attributed to misuse due to use error of over-torquing/over-engaging the driver with the screw head.

• 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: 18630058
• Report Number: 1220246-2024-00688
• Device Sequence Number: 20805588
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: 00888867263789
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 12/10/2024

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: 1392252
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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