MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 8.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 8.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/09/2021, it was reported by a arthrex employee via sems that an ar-1204as-85 flipcutter tip was damaged.This was discovered during use in a procedure on (b)(6) 2021.The fragment was removed and the case was completed by using a new ar-1204as-85.
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.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204as-85 was received for investigation.It was identified using digital caliper id: 011 that approximately 26.41mm of the distal end of the flipcutter shaft had been sheared off.The breakage site was consistent with interference between the device and a power tool.The fragment of the distal tip displayed signs of heat damage, and the cutting tip had fractured.

• Brand Name: FLIPCUTTER II, SHORT 8.5MM
• 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: 12896767
• Report Number: 1220246-2021-04017
• Device Sequence Number: 5734745
• Product Code: HWE
• UDI-Device Identifier: 00888867004429
• UDI-Public: 00888867004429
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/01/2022

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: 05/31/2023
• Device Model Number: FLIPCUTTER II, SHORT 8.5MM
• Device Catalogue Number: AR-1204AS-85
• Device Lot Number: 812883178
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown