MAUDE Adverse Event Report: ARTHREX, INC. TRIM-IT CANNULA INSERTION HANDLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TRIM-IT CANNULA INSERTION HANDLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
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.Complaint confirmed, evaluation confirmed the id of the handle met the specifications of drawing (b)(4), but did not meet the modification shown on note 3 of top level drawing (b)(4).See ncr-14358.
Event or Problem Description
It was reported that the ar-6590dt cannula obturator is not sliding into the ar-6590dh cannula insertion handle properly.It will lock in at the longest setting but it will not adjust to any shorter length than 15cm.The rep stated this is the first time they have used the item since ordering.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h10.Additional investigation summary: the most likely cause for the reported failure can be attributed to a manufacturing issue.

• Brand Name: TRIM-IT CANNULA INSERTION HANDLE
• 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: 19133005
• Report Number: 1220246-2024-02113
• Device Sequence Number: 17307970
• Product Code: LXH
• UDI-Device Identifier: 00888867199583
• UDI-Public: 00888867199583
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/28/2024

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: TRIM-IT CANNULA INSERTION HANDLE
• Device Catalogue Number: AR-6590DH
• Device Lot Number: 012031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown