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

Device Problems Dull, Blunt (2407); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 284870928
• Report Number: 1220246-2022-04376
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004207
• UDI-Public: 00888867004207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/14/2022
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other