MAUDE Adverse Event Report: Arthrex, Inc. BTB IB TightRope w FlipCutter III Drill; NON-DEGRADABLE FIXATN FASTENER

Model Number	BTB IB TightRope w FlipCutter III Drill
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 11-sep-2026, a sales representative reported via sems-07494925 that an ar-1288btbib-fc3 tightrope ii btb-ib implant system had an issue in which the flipcutter iii tip became bent and could not be fully closed for removal from the drill sleeve.This occurred while creating the femoral pcl tunnel.The flipcutter and drill sleeve were removed together, and the tunnel was found to be adequate for passing a suture, allowing the procedure to continue without complications.After the procedure, the device had to be cut with a pin cutter to remove the drill sleeve.This issue was discovered during a pcl reconstruction procedure on 11-sep-2026.No harm to the patient was reported.Additional information was received on 17-sep-2026: the bent tip was first identified upon completion of drilling the femoral pcl socket.The flipcutter was presumed to have become bent while deployed and retro-cutting, and the issue was identified when attempting to close the flipcutter.The reporter stated that unusually hard bone was encountered during the procedure.As a result, the flipcutter did not appear to cut as efficiently as expected, and additional in-line pressure was reportedly applied to facilitate cutting.No apparent torque or bending forces were applied to the device.The device reportedly came into contact with hard anatomy, specifically the femoral socket in the medial condyle, prior to the issue being observed.No portion of the flipcutter broke or separated from the device; therefore, there were no detached fragments to retrieve.An ar-1204ff was used as the replacement device to complete the procedure.The remaining components of the kit were used in the procedure.The procedure was delayed by approximately five minutes while the device was removed, and the femoral cortical hole was located to place a passing suture.The reporter was unable to confirm whether additional anesthesia was administered during this time.No adverse patient effects were reported during or following the procedure as a result of the event.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BTB IB TightRope w FlipCutter III Drill
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50947007
• Report Number: 1220246-2026-04961
• Device Sequence Number: 9499636
• Product Code: MBI
• UDI-Device Identifier: 00888867379961
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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): 09/30/2026

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 Model Number: BTB IB TightRope w FlipCutter III Drill
• Device Catalogue Number: AR-1288BTBIB-FC3
• Device Lot Number: 15452102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown