MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT; PIN, FIXATION, SMOOTH

Model Number ACL TIGHTROPE RT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported that during an issue with the tightrope has occurred during an acl reconstruction.During the surgery a tightrope rt was used on the femoral side and tightrope abs on the tibial side.During graft passage one of the white shortening strands of the tightrope rt snapped.When tugging on the graft on the tibial side the graft moved down the femoral tunnel and the button from the tightrope rt peeking through still attached to the graft.According to the surgeon there was no harm for patient, operator or third party reported.The surgeon used screws to fix the graft on the femur and the tibia to finish the surgery successfully.

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.

• Brand Name: ACL TIGHTROPE RT
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 15914515
• MDR Text Key: 305906103
• Report Number: 1220246-2022-05871
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019553
• UDI-Public: 00888867019553
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2022

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
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE RT
• Device Catalogue Number: AR-1588RT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1