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 Problems Break (1069); Loose or Intermittent Connection (1371); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/27/2022

Event Type  malfunction  

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.

Event Description

It was reported that during an all inside acl reconstruction one of the tensioning suture tapes cut through and detached from the button during tensioning of the tibial side.The button was still attached but lost the initial tension.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party.The surgery was finished successfully and the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update 30-nov-2022: further information was provided and revealed that the broken suture tape was removed from the patient however the button itself is inside the patient and it was not removed as the button was holding to the remaining suture and was loose.Since the initial suture broke from the knot above the button, it was not possible to tighten it any further.

• 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: 15958847
• MDR Text Key: 307795560
• Report Number: 1220246-2022-05915
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867319714
• UDI-Public: 00888867319714
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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: 14987895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1