MAUDE Adverse Event Report: ARTHREX INC. FLIPCUTTER II, SHORT 10.5MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-1204AS-105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2017
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 received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the inner shaft's distal end was broken off.The device met all material specifications as received.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 causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the base of the shaft of the cutter broke off during the back drilling of the pcl tibial tunnel.It was unflipped and removed; the technique was changed and they drilled a full tunnel to complete the case.Patient is male (b)(6).Follow-up investigation: the planned procedure was a pcl graftlink.Surgeon had to manually unflip the broken flipcutter ii to get the device and fragment, from the base of the device shaft, out of the patient, which caused a delay of approximately 20 minutes.No extra unplanned incisions were needed.Surgeon changed technique by drilling a full tunnel.It was the inner sleeve of the flipcutter that broke at the base.All pieces were retrieved from the patient.

• Brand Name: FLIPCUTTER II, SHORT 10.5MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6991284
• Report Number: 1220246-2017-00409
• Device Sequence Number: 13582793
• Product Code: MDM
• UDI-Device Identifier: 00888867004290
• UDI-Public: 00888867004290
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 12/01/2021
• Device Catalogue Number: AR-1204AS-105
• Device Lot Number: 635769909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/31/2017
• 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
• Patient Age: 22 YR