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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2021

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

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.

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mechanism was still intact, as the material remaining at the distal end of the ar-1204af-110 could be deployed and withdrawn as intended.The cause remains undetermined, although a probable cause can be attributed to user applied mechanical forces via prying/leveraging during use.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
• Type of Device: 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
• MDR Text Key: 278117123
• Report Number: 1220246-2021-03793
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004139
• UDI-Public: 00888867004139
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/23/2021
• Patient Sequence Number: 1