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

Model Number ACL TIGHTROPE RT

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/26/2019

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.

Event Description

It was reported during a revision acl procedure, upon inserting the femoral ar-4020c-07 fastthread biocomposite interference screw (lot: 10248522) the screw crumbled into multiple pieces after one and a half turns.The rep confirmed all broken pieces of the screw were retrieved by using a grasper.A second ar-4020c-07 from a different lot (lot: 10262903) was brought in.Upon inserting, the screw broke into two halves after one and a half turns.The rep confirmed all pieces were fully removed by using a grasper.Another manufacturer's screw was brought in and used to complete the procedure without further issue.Only one screw is available to return (lot: 10262903) as the other screw was discarded.The rep stated the revision took place due the patient re-tearing their acl.The original implanted arthrex tightrope and fiberwire were explanted during the revision.Additional information received on 08/01/2019: the rep confirmed the revision was due to re-injury and was not implant related.The primary procedure was a quad tendon autograft, soft tissue.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The surgeon revised with a btb autograft with interference screw fixation.During the revision procedure the femoral interference screw fractured at the tip during the first turn.This issue occurred twice.The surgeon tapped and notched and had a great angle.The following arthrex parts were implanted during the primary procedure, and explanted during the revision: ar-1588rt // lot: 10211964 // qty.:1.Ar-1588tb-3 // lot: 10223250 // qty.:1.Ar-1588tn // lot: 10216139 // qty.:1.

• 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: 8917030
• MDR Text Key: 155781782
• Report Number: 1220246-2019-01263
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019553
• UDI-Public: 00888867019553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: ACL TIGHTROPE RT
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 10211964
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2018
• 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