MAUDE Adverse Event Report: ARTHREX, INC. ACL REPAIR TIGHTROPE, WITH INTERNALBRACE; NON-DEGRADABLE FIXATN FASTENER

Model Number	ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the white suture of the device could not be loaded into the loop trap.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 02-apr-2024 it was confirmed that when loading the loop system with the wire loop, the wire loop broke.Update avoe 04-apr-2024 the failure occurred outside of the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-1588r-ib acl repair tightrope® was returned for investigation.Visual evaluation of the device noted that the suture threader was not returned.It was further noted that the white loop suture was broken, the loops were damaged and town, and the ends of the suture were frayed.Functional testing was unable to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used while passing the suture with the suture threader.Refer to investigation photos.

• Brand Name: ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: jared engle ; 8009337001
• MDR Report Key: 19110721
• Report Number: 1220246-2024-02027
• Device Sequence Number: 18204823
• Product Code: MBI
• UDI-Device Identifier: 00888867363656
• UDI-Public: 00888867363656
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
• Device Catalogue Number: AR-1588R-IB
• Device Lot Number: 15126271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown