MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	ACL TIGHTROPE
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during an acl procedure, the surgeon went to tighten the acl tightrope, ar-1588t, with arthrex tensioning handles.As he started to tighten, a strand broke at the femoral socket.There was no visible strand to try to grab so the surgeon had to make an additional incision to remove the tightrope from the joint.The case was then completed with no further incident.

• Brand Name: ACL TIGHTROPE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8636845
• Report Number: 1220246-2019-01105
• Device Sequence Number: 2387443
• Product Code: GAT
• UDI-Device Identifier: 00888867019614
• UDI-Public: 00888867019614
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: ACL TIGHTROPE
• Device Catalogue Number: AR-1588T
• Device Lot Number: 10202757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other