MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T15 HEXALOBE CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T15 HEXALOBE CANNULATED
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/22/2022
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
Whilst tightening hcs screw, cannulated t15 screwdriver shaft broke upon tightening.A second t15 cannulated screwdriver was used which also broke.All pieces were retrieved.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the damaged of the distal tip of the device.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: DRIVER SHAFT, T15 HEXALOBE CANNULATED
• 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: 15401857
• Report Number: 1220246-2022-05477
• Device Sequence Number: 17686884
• Product Code: LXH
• UDI-Device Identifier: 00888867197282
• UDI-Public: 00888867197282
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: DRIVER SHAFT, T15 HEXALOBE CANNULATED
• Device Catalogue Number: AR-8610D-43
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown