MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 8MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 8MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
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 that during an acl surgery, the flipcutter locked in tilted position.The surgeon had to create a complete femoral tunnel.Change of fixation mode with femoral screw instead of cortical button.The surgery was completed successfully, no harm for patient, user or third party reported.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204as-80 flipcutter was received for investigation.Attempts at functional testing identified that the flipcutter was unresponsive, and locked in the received position.Further visual inspection identified that the actuator tube had broken at the weld proximal to the handle, resulting in an inoperable actuating mechanism, and leading to the locked condition observed during functional testing.Material grade analysis testing identified that the returned ar-1204as-80 met all as-received specifications.As such, the observed condition is most likely the result of user applied mechanical forces via prying/leveraging the actuator tube during use.

• Brand Name: FLIPCUTTER II, SHORT 8MM
• 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: 10764233
• Report Number: 1220246-2020-02293
• Device Sequence Number: 3485980
• Product Code: HWE
• UDI-Device Identifier: 00888867004412
• UDI-Public: 00888867004412
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: FLIPCUTTER II, SHORT 8MM
• Device Catalogue Number: AR-1204AS-80
• Device Lot Number: 0006100122
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other