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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
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 05/23/2022, it was reported by an arthrex employee via sems that the tip of the ar-1204af-85 flipcutter broke when the surgeon was rotating the turning drill into the tibial canal.The broken piece was retrieved.This was discovered during a anterior cruciate ligament reconstruction procedure on (b)(6) 2022.The case was completed by using a new ar-1204af-85 different lot number.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the tip of the device was broken.It was also noted that the blade of the device is missing.The cause of this remains undetermined, however a probable cause can be attributed to prying/leveraging forces being applied to the device.It was also noted that the button of the device is missing.

• 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: 14603857
• Report Number: 1220246-2022-05043
• Device Sequence Number: 17533576
• Product Code: HWE
• UDI-Device Identifier: 00888867004252
• UDI-Public: 00888867004252
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/31/2022

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: 03/31/2026
• Device Model Number: 8.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-85
• Device Lot Number: 1088111141
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown