MAUDE Adverse Event Report: ARTHREX, INC. RETRACTABLE CANNULATED KNIFE, STRAIGHT; SAW BLADE

Model Number	RETRACTABLE CANNULATED KNIFE, STRAIGHT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
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 03/11/2024, it was reported by a sales representative via (b)(4) that (2) ar-6527-01 retractable cannulated knife handles could not slide even with pushing in the handle.This was discovered during a procedure.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the button of the retractable cannulated knife, straight had broken off.Functional testing was performed, and it was noted that the device did not work as required.The blade slid freely once and then got stuck.The most likely cause for the reported failure can be attributed to user error, due to the device due to excessive force/not being depressed when engaging the button to push forward.

• Brand Name: RETRACTABLE CANNULATED KNIFE, STRAIGHT
• Common Device Name: SAW BLADE
• 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: 18981716
• Report Number: 1220246-2024-01673
• Device Sequence Number: 6298991
• Product Code: GFA
• UDI-Device Identifier: 00888867039872
• UDI-Public: 00888867039872
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 08/29/2024

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: RETRACTABLE CANNULATED KNIFE, STRAIGHT
• Device Catalogue Number: AR-6527-01
• Device Lot Number: 15129790
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown