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	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that a ar-8770-01 driver shaft, and a ar-8943-08 screwdriver broke.This occurred during a case, with no patient effect reported.
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
Complaint confirmed.Upon visual inspection it was noted that the drive geometry at the distal tip of the returned ar-8770-01 had broken off.No fragments were returned for inspection.It was not indicated if a torque-indicating adapter had been used with the device.A probable cause is attributed to over-torquing/over-engaging the driver within the screw head.The cause remains undetermined.

• 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: 15923847
• Report Number: 1220246-2022-05887
• Device Sequence Number: 15128201
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: 00888867263789
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/06/2023

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: T25 HEXALOBE, ISO, CANN.
• Device Catalogue Number: AR-8770-01
• Device Lot Number: 012016
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown