MAUDE Adverse Event Report: ARTHREX, INC. 8.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	8.0 MM FLIP CUTTER II
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by an arthrex employee via sems that an ar-1204af-80 flipcutter was stuck and could not be restored to it's original position causing the surgeon to deviate from his intended technique and prepare a tunnel through the shin.This was discovered during an anterior cruciate ligament reconstruction of the right knee procedure on (b)(6) 2021.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204af-80 was received for investigation.Visual inspection identified that the cutting tip was loose at the distal tip of the device.Attempts at functional testing revealed that the actuating mechanism was inoperable, although the cutting tip was able to be flipped by hand.Further assessment revealed that the weld between the handle and the actuator tube had broken.The cause remains undetermined, although a probable cause can be attributed to user-applied mechanical forces to the shaft during use.

• Brand Name: 8.0 MM FLIP CUTTER II
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13087973
• Report Number: 1220246-2021-04211
• Device Sequence Number: 5423037
• Product Code: HWE
• UDI-Device Identifier: 00888867004245
• UDI-Public: 00888867004245
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 8.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-80
• Device Lot Number: 0330108163
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown