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

Model Number	8.5 MM FLIP CUTTER II
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a all inside knee arthroscopy with an flipcutter the device broke off inside the joint.The surgeon reported that there was no harm for patient, operator or third party.The surgery was finished successfully with a drill and a transtibial full tunnel drilling.
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-1204af-85 flipcutter ii was received for investigation.Visual inspection identified that the actuator tube had broken from the flipcutter ii assembly at the weld with the handle.Additionally, breakage was observed at the cutting tip, with circumferential damage worn into the outer diameter of the shaft proximal to the breakage site.The cause remains undetermined, although a probable cause can be attributed to user applied mechanical forces via prying/leveraging.

• Brand Name: 8.5 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: 12696466
• Report Number: 1220246-2021-03825
• Device Sequence Number: 12149597
• Product Code: HWE
• UDI-Device Identifier: 00888867004252
• UDI-Public: 00888867004252
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/26/2021

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: 10/31/2024
• Device Model Number: 8.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-85
• Device Lot Number: 929498182
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown