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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2022

Event Type  Injury  

Event Description

On 5/10/2022, it was reported by a distributor via email that an ar-1588rt acl tightrope sutures broke around the button and the graft lost tension and had to be removed from the patient.Surgeon then attached a fibertag to the graft and met resistance, the white shortening suture broke again around the button.The graft was once again removed and all the sutures were cut from construct.The allograft was inspected and noted it had become compromised.Surgeon opened another allograft and the procedure was completed with an trrt, tr abs with a 14mm abs button.This caused an hour of delay in the case.This was discovered during a revision aclr procedure on (b)(6) 2022.Additional information received on 5/11/2022: during this revision aclr procedure an ar-1588rtt acl fibertag tightrope was opened and attached to hamstring.When passing the femoral socket again, the white shortening sutures broke.Additional information requested.

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.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG
• 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: 14548287
• MDR Text Key: 292987212
• Report Number: 1220246-2022-05002
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308459
• UDI-Public: 00888867308459
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/31/2022

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 WITH FIBERTAG
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 14919627
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/31/2022
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other