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

Model Number	FLIPCUTTER II, SHORT 8.5MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
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 is expected but was not returned for evaluation.The 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 a knee arthroscopy procedure, the surgeon was using the 8.5mm flipcutter to drill the femoral tunnel and the tip of the flipcutter bent during drilling.The flipcutter was drilled out.Additional information requested.Additional information obtained: a full tunnel was drilled and in interference screw was used to complete the case.
Additional Manufacturer Narrative
Confirmed complaint.Visual evaluation revealed one side of the forked tip was bent and cracked; however, there were no pieces broken off the device or missing.Device met all material specifications as received.During testing, cutter would articulate only slightly due to the damaged tine but it could be returned to its straight, neutral angle.There was no damage or anomaly observed that would have contributed to the reported event.This type of damage may occur as a result of prying/leveraging during use.

• Brand Name: FLIPCUTTER II, SHORT 8.5MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7690758
• Report Number: 1220246-2018-00546
• Device Sequence Number: 10963797
• Product Code: MDM
• UDI-Device Identifier: 00888867004429
• UDI-Public: 00888867004429
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: No Information
• Device Expiration Date: 12/31/2022
• Device Model Number: FLIPCUTTER II, SHORT 8.5MM
• Device Catalogue Number: AR-1204AS-85
• Device Lot Number: 801580184
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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