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

Model Number ACL TIGHTROPE RT

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has 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 that during an acl reconstruction procedure, after the button was deployed into the lateral femoral cortex, the surgeon started to tension the suture and the suture broke immediately.There was never any instrument clamp on the suture during the graft preparation process or while passing the graft through tunnels.The surgeon had to pull the graft back out of the tunnel and make a bigger incision then pull all the acl tightropert through the lateral femoral cortex.

• 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: 8228362
• MDR Text Key: 132485860
• Report Number: 1220246-2019-00838
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019553
• UDI-Public: 00888867019553
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

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 Expiration Date: 03/31/2023
• Device Model Number: ACL TIGHTROPE RT
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 10206464
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2018
• 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