MAUDE Adverse Event Report: ARTHREX, INC. 12.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	12.0 MM FLIP CUTTER II
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
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 device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was initially reported that during a revision acl reconstruction with achilles-calcaneus allograft the arthrex flipcutter ii broke at the beginning of drilling the tibial socket.Surgeons were able to remove the broken blade which was near the tibial tunnel.This was reported to be a complex acl revision case with prominent deficiency of the bone in the tibia.For this reason the surgeon chose to use the largest flipcutter ii (12.0 mm) in order to accommodate the large bone block.After the flipcutter broke, to complete this portion of the procedure, the surgeon chose to use another manufacturer¿s device.Instead of using an all-inside technique, to create two sockets in the tibia, the surgeon used a conventional drill and created a full tibial tunnel.It was noted that the surgeon did use a flipcutter (10 mm) on the femur with no issues.Update 05-jun-2019: this was confirmed to have been a revision case of a previous acl reconstruction which was performed years prior.The reporter has no information regarding the previous acl reconstruction and therefore it cannot be confirmed if the original reconstruction involved any arthrex products.

• Brand Name: 12.0 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: 8699708
• Report Number: 1220246-2019-01146
• Device Sequence Number: 13995564
• Product Code: HWE
• UDI-Device Identifier: 00888867004153
• UDI-Public: 00888867004153
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• 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
• Report Date (Section B): 06/14/2019

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 Model Number: 12.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other