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

Model Number ACL TIGHTROPE RT W/ DEPLOYING SUTURE

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

Complaint is confirmed.Only the white suture was received.The suture appears to be frayed at both ends.The piece of suture which was returned measured approximately 23.5 inches in length.The most likely cause of this type of event is the suture being cut prematurely, being struck by another instrument or sharp object.

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.

Event Description

It was reported via e-mail that during surgery the fibertape with swaged needle, broke when the surgeon pulled it into the femur tunnel.It was the tension suture from the tightrope which broke.No harm was done to these sutures.Update 14-jan-2020: during acl tension of tightrope graftlink in the femur tunnel one of the tension suture broke down in the femur tunnel.It was not possible to see where.The broken piece was not retrieved from patient.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• 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: 9659030
• MDR Text Key: 187304980
• Report Number: 1220246-2020-01622
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867095533
• UDI-Public: 00888867095533
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

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 W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 10334028
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other