MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 7.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 7.5MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2019
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 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 the flipcutter ii, ar-1204as-75, was used in a pcl reconstruction procedure, while drilling the tunnel, metal powder was generated from the flipcutter and remained in the joint as the surgeon was unable to retrieve all the metal powder.The surgeon stopped using the flipcutter and completed the tunnel using another manufacturer's product.Additional information received 10/17/19: the surgeon drilled a full tunnel with the second flipcutter; however, he planned on drilling a full tunnel to begin with.There were no photos taken.
Additional Manufacturer Narrative
Complaint confirmed, some circumferential scuff marks were observed at the distal end of the device.Complainant's event is most likely caused by user mechanical damage to the device such as hitting the device with another device, prying/leveraging or excessive bending forces applied during use.

• Brand Name: FLIPCUTTER II, SHORT 7.5MM
• 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: 9287414
• Report Number: 1220246-2019-01399
• Device Sequence Number: 2448732
• Product Code: HWE
• UDI-Device Identifier: 00888867004405
• UDI-Public: 00888867004405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/09/2020

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: 05/31/2022
• Device Model Number: FLIPCUTTER II, SHORT 7.5MM
• Device Catalogue Number: AR-1204AS-75
• Device Lot Number: 713173990
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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