MAUDE Adverse Event Report: ARTHREX, INC. BTB TIGHTROPE W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number BTB TIGHTROPE W/ DEPLOYING SUTURE

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that during an anterior cruciate ligament plastic (semi-t) surgery the tensioning suture button of the device tore.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

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.

Manufacturer Narrative

Complaint is not confirmed.One unpackaged (b)(6) was received for investigation missing the white/black suture, the blue 2-0 suture loop, and attached needle.Though it cannot be confirmed that these were missing out of-box.Functional testing was performed and found that the assembled suture loop was tested, and functions as required.No additional functional testing was completed due to the disassembly of the device during use.No problem found.Visual evaluation noted fraying at the ends of the tensioning (white) suture and damage to the button.The most likely cause for the fraying can be attributed to use error of the device due to excessive force being used when tensioning the sutures.The most likely cause for the damage to the button can be attributed to use error due to grabbing/prying the button with another device.Refer to investigation photos.

• Brand Name: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Type of Device: 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: 18465613
• MDR Text Key: 332324458
• Report Number: 1220246-2024-00190
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867095366
• UDI-Public: 00888867095366
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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
• Device Operator: Health Professional
• Device Model Number: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-J
• Device Lot Number: 15101740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1