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

Model Number	T25 HEXALOBE, ISO, CANN.
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
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 a ar-8770-01 driver shafts tip broke off.This occurred during an ankle fusion procedure on (b)(6) 2022 when there was a bit of a struggle inserting the screw, and x-ray was taken where it showed the screw countersunk.They went to reverse the screw, and the driver tip broke off.There was no patient effect reported.No additional information provided.Additional information requested.
Event or Problem Description
Additional information was provided on 12/15/2022 where it was reported that the broken fragments were not retrieved.The screw was buried but was not in the joint.The screw would not cause an issue with the patient so the surgeon closed as normal.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in b5, h3, h6, and h10, and updated information in g1 and g3.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the report event is not confirmed.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause is attributed to over-torqueing/over-engaging the driver within the screw head.

• 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: jared engle ; 8009337001
• MDR Report Key: 16051404
• Report Number: 1220246-2022-05970
• Device Sequence Number: 6257938
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: 00888867263789
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/14/2024

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: 14932468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown