MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 9.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 9.5MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
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.
Event or Problem Description
It was reported during an acl procedure the flip-cutter broke when it was flipped inside the joint.There were 3 total small pieces that had to be retrieved.The surgeon found all of the missing pieces and removed them from the patient.Another flip-cutter was used to complete the case.There no further issues and the patient is fine to date.This was a younger female patient with hard bone.
Additional Manufacturer Narrative
It was reported that the device broke during the procedure.The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that one leg of the actuator tube broke off and one leg of the inner shaft had twisted.Functional testing was unable to be performed due to the damaged state of the device.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces while prying / leveraging the device in the noted hard patient bone.

• Brand Name: FLIPCUTTER II, SHORT 9.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11398301
• Report Number: 1220246-2021-02662
• Device Sequence Number: 11643718
• Product Code: HWE
• UDI-Device Identifier: 00888867004443
• UDI-Public: 00888867004443
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: FLIPCUTTER II, SHORT 9.5MM
• Device Catalogue Number: AR-1204AS-95
• Device Lot Number: 922896485
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1