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	Insufficient Information (4580)
Date of Event	09/21/2021
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
It was reported that during an all inside cruciate ligament surgery while inserting the flipcutter in the drill hole the device broke.The surgeon was able to retrieve the broken part and reported that the bone of the patient was very hard.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device.Therefore the implant has to be made smaller.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204af-110 was received for investigation.Visual inspection identified breakage at the cutting tip, with the remaining material noticeably warped at the breakage site.However, functional testing identified that the actuating mechanism was still intact, as the material remaining at the distal end of the ar-1204af-110 could be deployed and withdrawn as intended.The cause remains undetermined, although a probable cause can be attributed to user applied mechanical forces via prying/leveraging during use.

• 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
• MDR Report Key: 12616895
• Report Number: 1220246-2021-03793
• Device Sequence Number: 3973285
• Product Code: HWE
• UDI-Device Identifier: 00888867004139
• UDI-Public: 00888867004139
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 07/31/2024
• Device Model Number: 11.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-110
• Device Lot Number: 921395983
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/21/2021
• Patient Sequence Number: 1