MAUDE Adverse Event Report: ARTHREX, INC. 9.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	9.0 MM FLIP CUTTER II
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/10/2022, it was reported by a arthrex employee via sems that a ar-1204af-90 flipcutter broke.This occurred on (b)(6) 2022 during an unknown procedure when making the femoral tunnel, the flipcutter broke.There was no additional information provided, additional information requested.Additional information provided on 10/13/2022, it was reported that this incident occurred during a knee arthroscopy/acl reconstruction, and the broken fragments were fully retrieved.
Additional Manufacturer Narrative
The contrib (b)(4) 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 confirmed.Visual evaluation revealed that the cutter tip at the distal end of the shaft is broken.The most likely cause of this damage is probably hitting the device with another device or object, prying/leveraging or excessive bending forces applied during use.However, the cutter tip was not returned for investigation.The cause remains misuse.

• Brand Name: 9.0 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: 15698153
• Report Number: 1220246-2022-05666
• Device Sequence Number: 5622824
• Product Code: HWE
• UDI-Device Identifier: 00888867004269
• UDI-Public: 00888867004269
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 02/15/2023

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: 07/31/2026
• Device Model Number: 9.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-90
• Device Lot Number: 1208114326
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown