MAUDE Adverse Event Report: ARTHREX, INC. NANONEEDLE DIAGNOSTIC SHEATH KIT, 125MM; ARTHROSCOPIC ACCESSORIES

Model Number	NANONEEDLE DIAGNOSTIC SHEATH KIT, 125MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hand joint arthroscopy the trocar did not hold and slipped out.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.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
Complaint allegation is confirmed.One flexible obturator from an ar-3210-0050 nanoneedle scope diagnostic sheath kit was received for investigation.Visual evaluation noted that the flexible obturator was bent.Functional testing was unable to be performed due to the missing components.The most likely cause for the reported failure can be attributed to misuse due to the damage to the device.Refer to investigation photos.

• Brand Name: NANONEEDLE DIAGNOSTIC SHEATH KIT, 125MM
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 19180431
• Report Number: 1220246-2024-02368
• Device Sequence Number: 7147899
• Product Code: NBH
• UDI-Device Identifier: 00888867419223
• UDI-Public: 00888867419223
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/28/2024

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: NANONEEDLE DIAGNOSTIC SHEATH KIT, 125MM
• Device Catalogue Number: AR-3210-0050
• Device Lot Number: 3318136461
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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