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

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 282779985
• Report Number: 1220246-2021-04211
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004245
• UDI-Public: 00888867004245
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other