MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ® II RT WITH DEPLOYING SUTURE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number TIGHTROPE ® II RT WITH DEPLOYING SUTURE

Device Problem Positioning Problem (3009)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported that during an anterior cruciate ligament surgery one of the tensioning white sutures pulled through and the surgeon was not able to cinch the loop.The surgeon had to remove the graft and restart graft preparation.There was no harm for patient, operator or third party reported.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.(b)(6) 2022 update (b)(6): further information were provided that a part of the ar-1588rt-2j broke off.The surgeon was able to retrieve everything out of the patient.

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: TIGHTROPE ® II RT WITH DEPLOYING SUTURE
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 14978312
• MDR Text Key: 304605144
• Report Number: 1220246-2022-05227
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867319714
• UDI-Public: 00888867319714
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K202581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE ® II RT WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-2J
• Device Lot Number: 14009346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1