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

Catalog Number AR-1588RT-J

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that the acl tightrope was implanted during a procedure on (b)(6) 2017.During rehabilitation, the tightrope broke.*no further details, additional information requested.Follow-up investigation: the tightrope broke about 6 months post-op.A revision surgery took place in the "end of (b)(6) or early (b)(6)".Since it seemed that the tendon had healed, nothing replaced the device.

• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7577705
• MDR Text Key: 110450164
• Report Number: 1220246-2018-00203
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867095533
• UDI-Public: 00888867095533
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/07/2018

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: 05/01/2021
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 10048458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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