MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II ABS, IMPLANT OPEN; NON-DEGRADABLE FIXATION FASTENER

Model Number	TIGHTROPE® II ABS, IMPLANT OPEN
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 08/25/2022 by a sales representative via sems that an ar-1588r-ib tightropes flag came off and the suture was unable to pass.And an ar-1588tn-21 tightropes flag broke and the loop was unable to be completed.This was discovered during a case with no patient harm.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: TIGHTROPE® II ABS, IMPLANT OPEN
• Common Device Name: NON-DEGRADABLE FIXATION FASTENER
• 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: 19352190
• Report Number: 1220246-2024-03522
• Device Sequence Number: 15240821
• Product Code: MBI
• UDI-Device Identifier: 00888867371903
• UDI-Public: 00888867371903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE® II ABS, IMPLANT OPEN
• Device Catalogue Number: AR-1588TN-21
• Device Lot Number: 14971692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown