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

Model Number ACL TIGHTROPE RT

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device remained in patient and device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by a patient's attorney that the patient underwent an acl reconstruction procedure on (b)(6) 2016.Reporter disclosed that post-operatively the first reconstruction (initial surgery) had failed and an acl revision procedure (second surgery) was performed.The revision performed in the second procedure was also reported to have failed and a third surgery took place.During the third procedure the acl graft and hardware was found to be lax and a pin was malpositioned.The initial report did not specify the facility locations of each procedure or the procedure dates for the second and third surgery.No specific arthrex product numbers were provided in the initial report to confirm arthrex product involvement.The name of surgeon for third surgery was also not provided in initial report.Additional information obtained 7/10/18: initial surgery op report 5/16/16: a right knee acl reconstruction was performed using tibialis anterior allograft; posterior horn medial meniscus repair was attempted and did not work so a partial lateral meniscectomy was done.During this procedure several manufactures product were used, with one of those being an arthrex tightrope.The specific arthrex part number was not indicated in the operative report.After review of the operative report by an arthrex product manager it was determined that the most likely part number for the acl tightrope used was the tightrope rt (ar-1588rt).Revision op report 6/6/16: at the patient¿s first postoperative appointment it was determined the femoral fixation had failed and the tightrope was in the canal and the patient underwent a revision procedure at the same facility as the initial procedure by the same surgeon.The surgeon located the tightrope with a c-arm and found that the tightrope was stuck in the femur and stated there was no need to remove it.A graft was then placed on the tightrope and advanced through the femur anteriorly.

• 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: 7741918
• MDR Text Key: 115774426
• Report Number: 1220246-2018-00590
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE RT
• Device Catalogue Number: AR-1588RT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 08/02/2018
• 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
• Patient Age: 31 YR