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	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/02/2017
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 discarded 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.Lot number was not provided so device history record review cannot be performed.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.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.Device reported to have been discarded.
Event or Problem Description
It was reported that the blade of the flip cutter broke during a vkb (vorderes kreuzband = acl) all inside surgery.Fragment couldn't be removed from patient's body, surgery was successfully finished with this flip cutter.Additional information received from arthrex swiss on june 09: as per the surgeon, the broken cutter is fixed inside the drill tunnel and cannot be retrieved without further damage.According to the surgeon, there is no risk for the fragment to wander around inside the body.The post-op process is normal, the patient is doing fine.The patients femoral and tibial bone was immensely hard.

• 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: 6656268
• Report Number: 1220246-2017-00216
• Device Sequence Number: 16465052
• Product Code: MDM
• UDI-Device Identifier: 00888867004252
• UDI-Public: 00888867004252
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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 Catalogue Number: AR-1204AF-85
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2017
• Initial Report FDA Received Date: 06/21/2017
• 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