MAUDE Adverse Event Report: ARTHREX, INC. 10.5 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	10.5 MM FLIP CUTTER II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2nd sep 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-1204af-105, flipcutter® ii, 10.5 mm, the tip broke while drilling.This was detected during a pcl reconstruction with allograft and internal brace on (b)(6) 2025.The case was completed successfully by using a new ar-1204af-105.The tip was break off inside the patient and the broken piece was not retrieved from the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The failure was likely due to user error, such as improper bone preparation, misaligned insertion, or excessive force during drilling, which may have exceeded the device¿s structural limits and caused the tip to break.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: 10.5 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: 23094975
• Report Number: 1220246-2025-03950
• Device Sequence Number: 9321226
• Product Code: HWE
• UDI-Device Identifier: 00888867004122
• UDI-Public: (01)00888867004122(11)231001(17)280930(10)3276135445
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 09/26/2025

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: 10.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-105
• Device Lot Number: 3276135445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown