MAUDE Adverse Event Report: ARTHREX, INC. 11.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	11.0 MM FLIP CUTTER II
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
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 05/13/2022, it was reported by a sales representative via sems that during a pcl reconstruction procedure, when the surgeon was drilling the femoral tunnel with an ar-1204af-110 flipcutter, the tip struck the top of the femoral notch and the flipcutter split open and broke.The tip was retrieved from the patient and then an ar-1204af-105 flipcutter was used and during use the tip bent.The case was completed by using a third flipcutter without further issue.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204af-110 was received for investigation.Visual inspection identified that the cutting tip at the distal end of the flipcutter ii had broken.The remnants were noticeably bent/warped.However, functional testing revealed that the actuating mechanism was still operational.The remnants at the distal tip were able to be manipulated using the handle assembly.The cause remains undetermined, although a probable cause is attributed to user-applied mechanical forces.The bone quality encountered during the procedure was not provided.

• Brand Name: 11.0 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: 14548318
• Report Number: 1220246-2022-05005
• Device Sequence Number: 14763879
• Product Code: HWE
• UDI-Device Identifier: 00888867004139
• UDI-Public: 00888867004139
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: 05/31/2026
• Device Model Number: 11.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-110
• Device Lot Number: 1158112921
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown