MAUDE Adverse Event Report: ARTHREX, INC. 8.5 MM FLIP CUTTER II; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-1204AF-85
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Risk management will retain device.
Event or Problem Description
It was reported via fda medwatch letter (mw5069607) that during a posterior cruciate ligament reconstruction surgery of the right knee the surgeon was using the arthrex flipcutter ii, 8.5 mm, when a metal piece broke-off in the knee.Multiple attempts were made to remove the metal piece with use of fluoroscopy and arthroscope visualization.The surgeon was unable to retrieve and remove the metal piece broken from the flipcutter.Additional information received 6/28/2017: the facility has confirmed that the device has been retained.The facility policy requires that reportable device issues are to be retained at the facility.It will not be returned to arthrex for evaluation, but is available to evaluate on site.

• Brand Name: 8.5 MM FLIP CUTTER II
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6680683
• Report Number: 1220246-2017-00237
• Device Sequence Number: 13505511
• Product Code: MDM
• UDI-Device Identifier: 00888867004252
• UDI-Public: 00888867004252
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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: 09/01/2020
• Device Catalogue Number: AR-1204AF-85
• Device Lot Number: 527859271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/30/2017
• 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