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

Model Number	8.5 MM FLIP CUTTER II
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/24/2024, it was reported by a sales representative via e-mail that an ar-1204af-85 flipcutter® ii was getting hung up on the drill sleeve.This occurred during an acl procedure where the flipcutter® ii was drilled into the lateral femoral condyle utilizing the acl point to point guide and 3.5 drill sleeve.The flipcutter® ii was then opened to its 8.5mm diameter and the socket was retro-drilled to approximately 27mm until contacting the 7mm step on the drill sleeve.The flipcutter® ii was then turned back to what they thought was 3.5mm but when attempting to remove the flipcutter® ii it was getting hung up on the drill sleeve.They could not get the flipcutter® ii out of the sleeve and had to manually force it out of the bone.A new flipcutter® ii was opened for tibial drilling and it appeared that the blade on the flipcutter® ii had bent just barely restricting it from being removed from the drill sleeve.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded the cause of the reported failure.The most likely cause of the reported failure is user error, such as misaligned insertion, which caused the blades to get stuck on the drill sleeve.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.
Event or Problem Description
Additional information: this was discovered during an acl procedure and completed using another flipcutter iii.

• Brand Name: 8.5 MM FLIP CUTTER II
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18702285
• Report Number: 1220246-2024-00953
• Device Sequence Number: 6223721
• Product Code: HWE
• UDI-Device Identifier: 00888867004252
• UDI-Public: 00888867004252
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-85
• Device Lot Number: 2004118327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown