MAUDE Adverse Event Report: ARTHREX, INC. 8.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	8.0 MM FLIP CUTTER II
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/29/2022, it was reported by an arthrex employee via sems that an ar-1204af-80 flipcutter ii, 8 mm had an issue.When activating to drill mode and drilling in retrograde mode on (b)(6) 2022, the internal part of the flipcutter came out completely, in order to extract it they had to use a kelly forceps to deactivate and remove it.The device was discarded, but a picture was provided.This was discovered during use with no case/patient involvement.Additional information has been requested.On 2/1/2023, the following information was provided by the arthrex employee via email: this event occurred during a knee arthroscopy procedure.A piece of the instrument broke inside the patient and all fragments were retrieved.There was no information available on the bone quality of the patient, how the case was completed, and if the patient was fine to date.
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.

• Brand Name: 8.0 MM FLIP CUTTER II
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16403481
• Report Number: 1220246-2023-06315
• Device Sequence Number: 5759313
• Product Code: HWE
• UDI-Device Identifier: 00888867004245
• UDI-Public: 00888867004245
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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 Expiration Date: 12/31/2025
• Device Model Number: 8.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-80
• Device Lot Number: 1004108907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/20/2023
• Date Device Manufactured: 01/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown