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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

On 1/13/2023, it was reported by a sales representative via phone that qty.2 of an ar-1588rtt acl tightrope with fibertag had an issue.During a plc reconstruction procedure on (b)(6) 2023, when the surgeon was doing the final tensioning, the suture on the tightrope broke inside the patient.It was used to tension the graft inside the patient.The broken suture was removed and discarded.A second ar-1588rtt acl tightrope with fibertag with a different lot number was used for graft preparation and then the tensioning, and it broke again inside the patient upon final tensioning.Part of the suture remained in the patient and a tenodesis screw with an unknown part and lot number was used to affix the graft and to hold the tension.The procedure was completed successfully with no impact to the patient.The first device was removed and discarded, part of the second device was left in the patient.No pictures were taken.

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: 16263881
• MDR Text Key: 308873766
• Report Number: 1220246-2023-06196
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308459
• UDI-Public: 00888867308459
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE WITH FIBERTAG
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 14998640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2023
• Date Device Manufactured: 09/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1