MAUDE Adverse Event Report: ARTHREX, INC. 10.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	10.0 MM FLIP CUTTER II
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
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
On 12/18/2023, it was reported by an arthrex subsidiary employee that an ar-1204af-100 flipcutter ii broke in three pieces when the surgeon tried to drill the tibia bone socket.All the broken fragments were removed, and the case was completed using another ar-1204af-100 flipcutter ii.This was discovered during an aclr procedure on (b)(6) 2023.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional info: b4, h6 health effect - impact code.
Event or Problem Description
Additional information received on 1/11/2024: the case was delayed thirty minutes with no additional anesthesia.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Upon visual investigation, it was noted that the cutter tip, cutter pins, and one of the slots at the distal end of the shaft were broken off from the flipcutter® ii, 10 mm.The broken pieces were not returned for investigation.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: 10.0 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: emily shafer ; 8009337001
• MDR Report Key: 18494772
• Report Number: 1220246-2024-00281
• Device Sequence Number: 19716224
• Product Code: HWE
• UDI-Device Identifier: 00888867004115
• UDI-Public: 00888867004115
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

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: 12/31/2025
• Device Model Number: 10.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-100
• Device Lot Number: 0345108519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 08/02/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/08/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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