MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; SMOOTH FIXATION PIN

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
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
On 11/9/2023, it was reported by a distributor via (b)(4) that an ar-1588tb-1 tightrope abs button broke in half upon tensioning and got lodged into the tibial tunnel.The broken fragments were retrieved, and the case was completed successfully.This was discovered during an acl procedure on (b)(6) 2023.Additional information was received on 11/10/2023: the case was completed by opening another ar-1588tb-1 tightrope abs button.The case was delayed five minutes, and no additional anesthesia was needed.The patient suffered no negative effects on or after the surgery.
Additional Manufacturer Narrative
The complaint allegation cannot be confirmed as the device was not received for evaluation, and no pictures of the failure were received.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported and observed failure is user error.Specifically, the error involved applying excessive force, most likely by pulling the sutures.Direction for use.Dfu-0147 at revision 3.G.Precautions.1.Acl/pcl/ btb/rt/abs tightrope only: excessive force on the shortening suture strands 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.2.Load the acl/pcl tightrope button over the unspliced, thinner portion of the acl/pcl tightrope suture to assist assembly.Once assembled slide the acl/pcl tightrope button down to the thicker, spliced portion of the acl/pcl tightrope suture to help prevent disassembly.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• 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: 18279439
• Report Number: 1220246-2023-09246
• Device Sequence Number: 14999920
• Product Code: HTY
• UDI-Device Identifier: 00888867019638
• UDI-Public: 00888867019638
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: TIGHTROPE ABS, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 15128855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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