MAUDE Adverse Event Report: ARTHREX, INC. CANNULA W/ OBLIQUE WINDOW:11 X 134MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CANNULA W/ OBLIQUE WINDOW:11 X 134MM
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
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 06/04/2024, it was reported by a sales representative via (b)(4) that an ar-s3420-110-134 didn't pass or fit through the cannula.This was discovered during a case with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-s3420-110-134 cannula, w/ oblique window was received for investigation.Visual inspection of the device noted damaged to the diameter of the device, it was bent and slightly warped.Functional testing was conducted by attempting to pass the returned device through an ar-s3350-1015-139 spine endoscope and it was noted that the endoscope could not pass or fit through the cannula.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.

• Brand Name: CANNULA W/ OBLIQUE WINDOW:11 X 134MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19657693
• Report Number: 1220246-2024-06552
• Device Sequence Number: 6540565
• Product Code: LXH
• UDI-Device Identifier: 00888867427860
• UDI-Public: 00888867427860
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/25/2024

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: CANNULA W/ OBLIQUE WINDOW:11 X 134MM
• Device Catalogue Number: AR-S3420-110-134
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown