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

Model Number ACL TIGHTROPE RT

Device Problems Entrapment of Device (1212); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/05/2018

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 part remains in the patient.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during an acl tightrope procedure, the surgeon was implanting an acl tightrope when the suture became loose in the surgeon¿s hand and the button stayed in the patient.The surgeon attempted to retrieve the button but was unsuccessful.The case was completed by opening and implanting a second acl tightrope.Patient is a male.

• 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: 7684885
• MDR Text Key: 113872084
• Report Number: 1220246-2018-00538
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019553
• UDI-Public: 00888867019553
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: ACL TIGHTROPE RT
• Device Catalogue Number: AR-1588RT
• Device Lot Number: F153361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2018
• Date Device Manufactured: 08/01/2017
• 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