MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE; SMOOTH FIXATION PIN

Model Number TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 11/28/2023

Event Type  Injury  

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

On 17th december 2023, it was reported by a sales representative via email that an ar-1588rtt acl fibertag tightrope potentially unthreaded from locking sock when untangled.This was detected on 28th november 2023 during a revision acl with quads graft procedure.8th jan 2024 - the procedure was completed successfully as the tightrope was unstitched from the quad graft and re-stitched with a new implant.12th jan 2024 - the following part numbers were used in the original acl procedure: ar-1588rt, ar-1588tn and ar-1588tb-4.

• Brand Name: TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
• Type of Device: 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: 18639766
• MDR Text Key: 334530151
• Report Number: 1220246-2024-00751
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
• Device Catalogue Number: AR-1588TB-4
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other