MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II BTB, RECON IB¿; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE FASTENER, FIXATION, NON-DEGRADAB

Model Number TIGHTROPE® II BTB, RECON IB¿

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/17/2022

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 on (b)(6) 2022 by a sales representative via email that an 1588btb-ib tightrope blue flag broke off while passing suture and the suture was unable to be retrieved to complete the construct.This was discovered during a case and broke inside the joint space.

• Brand Name: TIGHTROPE® II BTB, RECON IB¿
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE FASTENER, FIXATION, NON-DEGRADAB
• 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: 15362324
• MDR Text Key: 305593439
• Report Number: 1220246-2022-05443
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867319677
• UDI-Public: 00888867319677
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE® II BTB, RECON IB¿
• Device Catalogue Number: AR-1588BTB-IB
• Device Lot Number: 14951592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2022
• Date Device Manufactured: 04/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1