MAUDE Adverse Event Report: ARTHREX, INC. 9.5 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	9.5 MM FLIP CUTTER II
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/27/2019
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.It has been reported that the risk manager will not release the device.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during an acl reconstruction procedure, the surgeon was drilling with a 9.5mm flipcutter, ar-1204af-95, and the blade snapped off.The blade could not be located.The surgeon then opened a 10mm flipcutter, ar-1204af-100, and the tip of this flipcutter also broke while the surgeon was drilling.The broken blade was clearly visible and easily removed from the joint using a grasper.The patient had an x-ray post-case which confirmed that the broken blade of the 9.5mm flipcutter was still in the knee joint.Patient had to go under ga again so that the surgeon could retrieve the blade.Additional information provided 7/3/19: the surgeon ended up drilling a full tibial tunnel with the reusable 10mm reamer (ar-1214) , rather than a 35mm socket he would have created with the flipcutter.
Additional Manufacturer Narrative
Complaint confirmed, the blade was found to have detached from the device.Additionally, one leg of the inner shaft distal end is twisted and bent, and one leg of the actuator tube broke off.This event is most likely caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces applied during use.

• Brand Name: 9.5 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: 8817409
• Report Number: 1220246-2019-01212
• Device Sequence Number: 2838297
• Product Code: HWE
• UDI-Device Identifier: 00888867004276
• UDI-Public: 00888867004276
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/12/2019

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 Expiration Date: 02/29/2024
• Device Model Number: 9.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-95
• Device Lot Number: 905691211
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other