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

Model Number	RETRACTABLE CANNULATED KNIFE, STRAIGHT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy the device did not flip and therefore did not work.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.
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
This report is being submitted to provide additional information in d8/9, h3, h6: type of investigation, investigation findings, investigation conclusions, g3, and h10.Complaint allegation is confirmed.Visual inspection identified the retractable knife of the retractable cannulated knife, straight had chipped on one side of the knife.Functional testing revealed that the knife did not slide freely when the button was depressed and pushed forward.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.

• 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: 18773440
• Report Number: 1220246-2024-01110
• Device Sequence Number: 18067873
• Product Code: GFA
• UDI-Device Identifier: 00888867039872
• UDI-Public: 00888867039872
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 06/28/2024

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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