MAUDE Adverse Event Report: ARTHREX, INC. 8.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	8.0 MM FLIP CUTTER II
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex employee via email that for an ar-1204af-80, flipcutter® ii, 8 mm, the drill bit did not flip during slow backward pulling of the drill in the articular cavity to prepare the bone channel so thicker bone passages could not be prepared.This was detected during use in a total internal anterior fork ligament reconstruction procedure on (b)(6) 2023 when the surgeon had prepared the lateral tibial tunnel and inserted the ar-1204af-80 flipcutter ii deep into the cuff to open the tunnel into the joint cavity.The procedure was completed successfully as a new ar-1204af-80 was used.There was no patient harm and no secondary procedure needed.
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
Complaint allegation is confirmed.One unpackaged, flipcutter® ii, 8 mm, ar-1204af-80, batch 2187123266, was received for investigation.Upon visual inspection, it was noted that the cutter tip was damaged: it was loose, and it had striation marks on it.Functional testing could not be performed due to the damage of the device.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or prying/leveraging during use.

• Brand Name: 8.0 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: jared engle ; 8009337001
• MDR Report Key: 19557884
• Report Number: 1220246-2024-05910
• Device Sequence Number: 14665443
• Product Code: HWE
• UDI-Device Identifier: 00888867004245
• UDI-Public: 00888867004245
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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 Model Number: 8.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-80
• Device Lot Number: 2187123266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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