MAUDE Adverse Event Report: ARTHREX, INC. 6.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6.0 MM FLIP CUTTER II
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via the phone that an ar-1204af-60 flipcutter locked and would not return to closing position.This was discovered during use in a knee procedure w/ meniscal root repair on (b)(6) 2022.The surgeon use the flipcutter to create the femoral socket.After reaming the blade cold-welded and would not close.The surgeon removed the ar-1204f-60 with the blade in the open position, using the entire femoral tunnel to be larger than expected.The knee scorpion suture passer ar-12990, was used to pass the sutures for the posterior repair.The surgeon used three different ar-12990 knee scorpion with three ar-12990n's 2 of (lot 1345569) both needles delaminating inside the ar-12990 while the surgeon was trying to pass through (lot 14109312) pushed lateral while passing through jamming inside the trap door.The case was completed using a 4th ar-12990n with out issue.The sales representative stated 30-35 mins was added to the procedure, requiring additional anesthesia.
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.

• Brand Name: 6.0 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13397818
• Report Number: 1220246-2022-04376
• Device Sequence Number: 12235535
• Product Code: HWE
• UDI-Device Identifier: 00888867004207
• UDI-Public: 00888867004207
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 01/31/2022

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: 07/31/2026
• Device Model Number: 6.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-60
• Device Lot Number: 1242115228
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/31/2022
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown