MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE, ABS, IMPLANT; SMOOTH FIXATION PIN

Model Number	TIGHTROPE, ABS, IMPLANT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the loop of the device is damaged during a reconstruction surgery and the device didn`t lock up when pinched.No part of the device broke inside the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure is user error.Per dfu-0147-4 at revision 0.G.Precautions 1.Acl/pcl/ btb/rt/abs tightrope only: excessive force on the shortening suture strands may break the strands and impair ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket and the graft stability is verified by pulling distally on the graft.

• Brand Name: TIGHTROPE, ABS, IMPLANT
• Common Device Name: SMOOTH FIXATION PIN
• 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: 18415645
• Report Number: 1220246-2023-09703
• Device Sequence Number: 2933247
• Product Code: MAI
• UDI-Device Identifier: 00888867019706
• UDI-Public: 00888867019706
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K221128
• 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
• Report Date (Section B): 12/28/2023

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 Expiration Date: 10/31/2025
• Device Model Number: TIGHTROPE, ABS, IMPLANT
• Device Catalogue Number: AR-1588TN
• Device Lot Number: 12082834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2020
• 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