MAUDE Adverse Event Report: ARTHREX, INC. 10.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	10.0 MM FLIP CUTTER II
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
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 9/30/2022, it was reported by an arthrex employee via sems that an ar-1204af-100 flipcutter® ii, 10 mm had an issue.When carrying out the procedure on (b)(6) 2022, the tip of the flipcutter was broken, it was possible to see as if it had been removed and later the part with which the retro-perforation was carried out was disassembled.This was discovered during use with no case/patient involvement and no patient injury.Additional information has been requested.
Additional Manufacturer Narrative
This supplemental submission is due to additional event details received.On 10/10/2022, the arthrex employee provided the following information via email: this event occurred during a lca procedure.The broken part remained inside the joint, but it was then completely recovered, and the fragment was fully retrieved.The bone quality of the patient was not provided.The case was completed by using another flipcutter of a smaller size, part and lot number were unknown.The patient is fine to date, and so far there were no alarms about the patient's condition.
Additional Manufacturer Narrative
Review of this complaint confirmed the event summary code selection and an investigation including a product history review was performed as required.The complaint device was not returned for investigation, however, picture(s) of the complaint device were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was not able to be determined.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per (b)(4).
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the cutter tip broken.However, without return of the device and broken piece for physical evaluation.No change in harm was identified.The cause remains undetermined.

• Brand Name: 10.0 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: 15538147
• Report Number: 1220246-2022-05570
• Device Sequence Number: 6107512
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2023

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 Model Number: 10.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-100
• Device Lot Number: 1315117173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 09/15/2022; 09/15/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/11/2022; 12/29/2022; 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown