MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 6MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 6MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 04/04/2023 by a arthrex employee via (b)(4) that an ar-1204as-60 flipcutter after creating the socket, the ar-1204as-60 and the hollow drill (drill guide) got stuck and could not be removed.No patient harms.Case involvement, no patient effect.
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.Complaint is not confirmed.Functional testing found that the device function as required.No problem found.Visual evaluation noted that the device does not have any issues.

• Brand Name: FLIPCUTTER II, SHORT 6MM
• 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: 19373424
• Report Number: 1220246-2024-03669
• Device Sequence Number: 7678232
• Product Code: HWE
• UDI-Device Identifier: 00888867004375
• UDI-Public: 00888867004375
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: FLIPCUTTER II, SHORT 6MM
• Device Catalogue Number: AR-1204AS-60
• Device Lot Number: 2207123805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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