MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 11.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 11.5MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
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 has not returned for evaluation.The device has been reported to have been discarded.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 by a sales rep who was present that the ar-1204as-115, 11.5mm flipcutter, was used in a knee arthroscopy procedure on (b)(6) 2019.Per the sales rep, the surgeon performed the flipcutter technique correctly.He pre-drilled in the femur with a 3.5mm drill until the inside portion of the medial condyle was reached.Once the 3.5mm predrill was completed, the 11.5mm flipcutter was introduced through the predrilled hole into the joint.Per the sales rep, the surgeon correctly deployed the flipcutter completely, and then he performed the retrograde drilling action.The socket was created without issue.However, the issue came when it was time to straighten out the flip cutter and pull it out of the 3.5mm step drill sleeve.The flip cutter was straightened; however, the flipcutter could not be removed from the joint.The doctor used a pituitary and probe to do his best to straighten out the flipcutter as much as possible, however the flipcutter would not straighten out completely, making it impossible to pull it out of the 3.5mm step drill sleeve.The surgeon ended up having to pull the step drill sleeve out of the cortex of the lateral epicondyle in order to remove the flipcutter from the joint.This caused the surgeon to lose his place on the cortex, the 3.5mm cortex hole was compromised and required an extension button on the femoral suspension implant causing the surgeon to introduce a passing suture into the femoral socket.The issue caused a 30 min delay in case.

• Brand Name: FLIPCUTTER II, SHORT 11.5MM
• 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: 8375672
• Report Number: 1220246-2019-00922
• Device Sequence Number: 2839298
• Product Code: HWE
• UDI-Device Identifier: 00888867004313
• UDI-Public: 00888867004313
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: 04/30/2023
• Device Model Number: FLIPCUTTER II, SHORT 11.5MM
• Device Catalogue Number: AR-1204AS-115
• Device Lot Number: 811082736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/27/2019
• 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