MAUDE Adverse Event Report: ARTHREX, INC. 7.5 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	7.5 MM FLIP CUTTER II
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
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 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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that a ar-1204af-75 (7.5 mm flip cutter ii) was unable to be un-flipped after it has been flipped in the patient's knee.This occurred during use in an acl procedure on (b)(6) 2023.Procedure was completed successfully with no patient harm, after reaming full tibia tunnel instead of retrograde drilling.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h3, h6: type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1, g3.The complaint is confirmed based on the customer provided video, which displays that the cutter tip did not retract to the original position.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force use, misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: 7.5 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: 17022970
• Report Number: 1220246-2023-06804
• Device Sequence Number: 6872232
• Product Code: HWE
• UDI-Device Identifier: 00888867004238
• UDI-Public: 00888867004238
• 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): 06/13/2024

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 Model Number: 7.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-75
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown