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

Model Number	FLIPCUTTER II, SHORT 8.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery while drilling the device broke in the patient.Surgeon managed to remove the retained piece of metal after a bit of a struggle and then checked it against the flipcutter to see if complete.However, the surgeon was still unsure if there was nothing retained in the patient.A washout of the whole knee was done athroscopically.A series of x-rays was done to see if it will show any metal bits retained in the knee so as to retrieve them if any.Surgeon and assistant went through all the suction bottles to see the piece of metal came out during the wash but could not find any.No further information was provided.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: FLIPCUTTER II, SHORT 8.5MM
• 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: 21304352
• Report Number: 1220246-2025-00157
• Device Sequence Number: 8020193
• Product Code: HWE
• UDI-Device Identifier: 00888867004429
• UDI-Public: (01)00888867004429(11)210401(17)260331(10)1095111291
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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 Expiration Date: 03/31/2026
• Device Model Number: FLIPCUTTER II, SHORT 8.5MM
• Device Catalogue Number: AR-1204AS-85
• Device Lot Number: 1095111291
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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