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

Model Number TIGHTROPE ® II BTB WITH DEPLOYING SUTURE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2022

Event Type  Injury  

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

On (b)(6) 2022, it was reported by a sales representative via email that an ar-1588btb-2j tightrope ii btb free rail would not pull through with the wire and wire broke.Another one was used to complete the case.This was discovered while assembling the graft on the back table during a procedure on (b)(6) 2022.Additional information received on (b)(6) 2022: this was discovered on the back table, while prepping the graft, during a btb aclr procedure.Case was competed by switching to a two-incision approach and used an ar-4020c-08 screw instead of a tightrope.

• Brand Name: TIGHTROPE ® II BTB 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: 15905413
• MDR Text Key: 304710562
• Report Number: 1220246-2022-05847
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867319660
• UDI-Public: 00888867319660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-2J
• Device Lot Number: 14991979
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2022
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other