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 Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On07/06/2022, it was reported by a arthrex employee via (b)(4) that a ar-1204af-100 flipcutter does not work.This occurred on (b)(6) 2022 during a knee arthroscopy + acl + pcl.The case was completed.There was no patient effect reported.No additional information provided.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• 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: jared engle ; 8009337001
• MDR Report Key: 19385797
• Report Number: 1220246-2024-03770
• Device Sequence Number: 4035737
• Product Code: HWE
• UDI-Device Identifier: 00888867004115
• UDI-Public: 00888867004115
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 05/23/2024

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: 10.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-100
• Device Lot Number: 1335117582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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