MAUDE Adverse Event Report: FLIPCUTTER II, SHORT 10.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 10.5MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that qty.2 of an ar-1204as-105 flipcutter broke during a knee acl reconstruction.The first flipcutter was flipped in the knee to retrodrill a tibial tunnel and upon deployment of the cutter, the blade shot off the instrument and into the joint.The fragment was removed and a second flipcutter was utilized.When the surgeon was using the second flip cutter, it was self deploying in the knee post retrograde flipping.The mechanism would not lock the cutter straight following deployment, and was flipping spontaneously in the joint upon retraction.The case was completed by using a third ar-1204as-105.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the cutting tips had fractured off of the actuating tubes.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: FLIPCUTTER II, SHORT 10.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• MDR Report Key: 12659181
• Report Number: 1220246-2021-03810
• Device Sequence Number: 4480730
• Product Code: HWE
• UDI-Device Identifier: 00888867004290
• UDI-Public: 00888867004290
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/25/2021

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: 07/31/2023
• Device Model Number: FLIPCUTTER II, SHORT 10.5MM
• Device Catalogue Number: AR-1204AS-105
• Device Lot Number: 816684178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 10/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1