MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 10.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 10.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2022
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 (b)(6) 2022 it was reported by a sales representative via sems that an ar-1204as-105 flip-cutter ii broke during a case.All was retrieved.
Additional Manufacturer Narrative
The complaint is confirmed.(1) unpackaged ar-1204as-105 was received for evaluation.Visual inspection revealed the 10.5 mm cutter tip, component c2363-10, and the cutter tip pin, component c2364-01 are missing.The distal portion of the actuator tube, component c2363-02, was broken off, and the two protruding features of the distal end of the shaft, component c2361-02, have been twisted and broken.Remnants of tissue were present in the sample.Without additional information, the cause remains undetermined.A probable cause could be attributed to impact with another device or hard bone during the procedure.

• Brand Name: FLIPCUTTER II, SHORT 10.5MM
• 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: 13929011
• Report Number: 1220246-2022-04665
• Device Sequence Number: 5563217
• Product Code: HWE
• UDI-Device Identifier: 00888867004290
• UDI-Public: 00888867004290
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 02/28/2025
• Device Model Number: FLIPCUTTER II, SHORT 10.5MM
• Device Catalogue Number: AR-1204AS-105
• Device Lot Number: 0065101805
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown