MAUDE Adverse Event Report: ARTHREX, INC. 12.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	12.0 MM FLIP CUTTER II
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2021
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 on (b)(6) 2020 the surgeon was performing a right knee posterior cruciate ligament and posterior lateral corner reconstruction.Intra-operatively the tibial and femoral bone sockets were reamed with an ar-1204af-120, 12mm flipcutter ii (lot 816684176).To lengths of 40mm and 35 mm respectively.The blade was changed from cutting orientation back to drilling orientation inside the femoral socket without visual observation.The graft was passed, tensioned and fixated with button.This was all completed without any team members noticing any issue.Surgeon took a post operative radiographic image after the sterile dressings were placed and discovered a retained broken blade from the flipcutter ii.The patient had undergone a lengthy surgery with maximum tourniquet time and surgeon made the decision to bring patient back at a later date to arthroscopically remove the retained fragment.Additional information 1/6/2020: procedure scheduled for (b)(6) 2020 to remove the retained fragment.Additional information 1/11/2021: it has been confirmed that the flipcutter ii fragment was arthroscopically removed from the patient on (b)(6) 2021.The flipcutter ii and fragment are being returned for evaluation.
Additional Manufacturer Narrative
Complaint confirmed, the cutter tip broke with the remaining fragment still assembled.The mechanism was found to remain functional.Complainant's event is most likely caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces applied during use.

• Brand Name: 12.0 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
• MDR Report Key: 11228593
• Report Number: 1220246-2021-02488
• Device Sequence Number: 11788286
• Product Code: HWE
• UDI-Device Identifier: 00888867004153
• UDI-Public: 00888867004153
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 06/30/2023
• Device Model Number: 12.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-120
• Device Lot Number: 816684176
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other