MAUDE Adverse Event Report: ARTHREX, INC. TROCAR F/ TAP/FEN,HF 4MM SCP SHTH W/HDLE; ARTHROSCOPE AND ACCESSORIES

Model Number	TROCAR F/ TAP/FEN,HF 4MM SCP SHTH W/HDLE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft is bent.There was no harm for the patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos provided.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: TROCAR F/ TAP/FEN,HF 4MM SCP SHTH W/HDLE
• Common Device Name: ARTHROSCOPE AND 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: 19551270
• Report Number: 1220246-2024-05890
• Device Sequence Number: 6715827
• Product Code: NBH
• UDI-Device Identifier: 00888867030404
• UDI-Public: 00888867030404
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: TROCAR F/ TAP/FEN,HF 4MM SCP SHTH W/HDLE
• Device Catalogue Number: AR-3375-4002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown