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

Model Number	TIGHTROPE® II BTB, RECON IB¿
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during an anterior cruciate ligament surgery the suture tore while tightening the loop.The suture tore during implant insertion.According to the surgeon no harm for patient, operator or third party occurred.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.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-1588btb-ib batch 15169840 was received for investigation.Functional testing was not performed due to the fact that the device loops were pull one side.A visual evaluation revealed that the device's sutures were damaged or torn.One of the loops vanished because the suture was pulled tight, closing the loop entirely.The most likely cause for the reported failure is a user error.Dfu-0147, excessive force on the shortening suture strands may break the strands and impair the ability to seat the implant fully.

• Brand Name: TIGHTROPE® II BTB, RECON IB¿
• Common Device Name: NON-DEGRADABLE FIXATN 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: jared engle ; 8009337001
• MDR Report Key: 19628726
• Report Number: 1220246-2024-06477
• Device Sequence Number: 8793306
• Product Code: MBI
• UDI-Device Identifier: 00888867319677
• UDI-Public: 00888867319677
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K231857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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 BTB, RECON IB¿
• Device Catalogue Number: AR-1588BTB-IB
• Device Lot Number: 15169840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown