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	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
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 (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint cannot be confirmed.One unpackaged ar-1204af-90 flipcutter ii (no batch number present) was received for investigation.Visual inspection identified deep, horizontal rings worn around the outer diameter of the flipcutter, proximal to the cutting tip.However, despite the surface damage to the actuator tube, the cutting tip was still able to be flipped.The device was found to be functional.
Event or Problem Description
It was reported that during dt4 surgery both blades did not overbalanced.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update, 14-jan-2021 -sac.Failure is can insert first blade and after second one into the tunnel because blade didn¿t worked.

• 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: 19079053
• Report Number: 1220246-2024-01940
• Device Sequence Number: 20301084
• Product Code: HWE
• UDI-Device Identifier: 00888867004269
• UDI-Public: 00888867004269
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/10/2024

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: 11/30/2024
• Device Model Number: 9.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-90
• Device Lot Number: 933899367
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2019
• 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