MAUDE Adverse Event Report: ARTHREX, INC. 9.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	9.0 MM FLIP CUTTER II
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/03/2021, it was reported by a sales representative via e-mail that an ar-1204af-90 flipcutter would not flip once the femoral tunnel was drilled.The surgeon was able to pry the flipcutter blade back using a grasper.This was discovered during use in a acl reconstruction (b)(6) 2021.The case was completed by using a new ar-1204af-90.
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.One unpackaged ar-1204af-90 (no batch indicator present) was received for investigation.Visual inspection concluded without the observance of any external damage to the flipcutter.However, functional testing revealed that the actuating mechanism allowed the cutting tip to flip approx.90°, although it was not possible to straighten the cutting tip back out using the handle.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces to the shaft during use.

• Brand Name: 9.0 MM FLIP CUTTER II
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19332075
• Report Number: 1220246-2024-03410
• Device Sequence Number: 15181242
• Product Code: HWE
• UDI-Device Identifier: 00888867004269
• UDI-Public: 00888867004269
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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 Expiration Date: 06/30/2026
• Device Model Number: 9.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-90
• Device Lot Number: 1174113430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown