MAUDE Adverse Event Report: ARTHREX, INC. 11.0 MM FLIP CUTTER II; POWERED SURG ORTHOPEDIC INSTR

Model Number	11.0 MM FLIP CUTTER II
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
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, (b)(6) 2021 -sac failure can't insert first blade and after second one into the tunnel because blade didn¿t work.
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-110 flipcutter ii (no batch number present) was received for investigation.Visual inspection identified a scuff marking across the cutting tip.No breakage, however, was present.Functional testing determined that the cutting tip would not actuate, although no weld damage was present across the outer diameter of the actuator tube.The observed condition is most likely the result of internal damage to the actuating mechanism, caused by prying/leveraging the device during use.

• Brand Name: 11.0 MM FLIP CUTTER II
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 19460093
• Report Number: 1220246-2024-04841
• Device Sequence Number: 7972708
• Product Code: HWE
• UDI-Device Identifier: 00888867004115
• UDI-Public: 00888867004115
• 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): 06/04/2024

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: 05/31/2024
• Device Model Number: 11.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-110
• Device Lot Number: 914493988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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