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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a hip arthroscopy, the device got jammed, the button to push/retract the knife didn't work.Per complaint reporter there was no harm for patient, operator or third party.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
Additional information: d9, g3, h3, h6.One unpackaged ar-6527-01, retractable cannulated knife, straight, batch number 15248695, was received for investigation.Visual inspection revealed that the shaft was bent, and the handle was stuck in the upright position.Functional testing showed that the cutter failed to retract and extend as intended.The most likely cause is user error, resulting from excessive force applied while prying or leveraging the device during use.Complaint allegation is confirmed.

• 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: 22542676
• Report Number: 1220246-2025-02967
• Device Sequence Number: 15570367
• Product Code: GFA
• UDI-Device Identifier: 00888867039872
• UDI-Public: (01)00888867039872(11)240515(17)290430(10)15248695
• 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): 09/08/2025

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: 15248695
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown