MAUDE Adverse Event Report: ARTHREX, INC. BTB TIGHTROPE; SMOOTH FIXATION PIN

Model Number	BTB TIGHTROPE
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)/2023, it was reported by an arthrex employee via email that a btb tightrope chinese mesh got stuck and would not advance.The surgeon could not unlock the mesh, and the button failed to rise.The case was completed using another tightrope.This was discovered during a procedure on (b)(6)2023.Additional information requested.
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.
Additional Manufacturer Narrative
The complaint allegation is confirmed.Upon evaluating the customer-provided photo, it was observed the suture loop system was broken.The sutures were frayed most likely due to excessive force.The most likely cause(s) of reported failure is user error following the surgical technique.According to dfu-0147.G.Precautions.1.Acl/pcl/btb/rt/abs tightrope only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket and the graft stability is verified by pulling distally on the graft.
Event or Problem Description
Additional information received on 1/2/2024: this was discovered during an acl procedure.

• Brand Name: BTB TIGHTROPE
• Common Device Name: SMOOTH FIXATION PIN
• 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: emily shafer ; 8009337001
• MDR Report Key: 17441654
• Report Number: 1220246-2023-07384
• Device Sequence Number: 2735863
• Product Code: HTY
• UDI-Device Identifier: 00888867019515
• UDI-Public: 00888867019515
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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 TIGHTROPE
• Device Catalogue Number: AR-1588BTB
• Device Lot Number: 14543477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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