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

Model Number NANONEEDLE DIAGNOSTIC SHEATH KIT, 125MM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: NANONEEDLE DIAGNOSTIC SHEATH KIT, 125MM
• Type of Device: 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
• MDR Text Key: 341530152
• Report Number: 1220246-2024-02368
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867419223
• UDI-Public: 00888867419223
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1