MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS AC TIGHTROPE REPAIR SYSTEM; WASHER, BOLT, NUT

Model Number	KNOTLESS AC TIGHTROPE REPAIR SYSTEM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
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 the patient had to be revised today due to a new clavicle elevation.The suture loop was firm and intact above the button but the tension had given way.The problem was noticed after the surgery.The item was completely recovered and a new item was implanted.The old implanted device was disposed.There was no harm for the patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
Complaint allegation is confirmed based on customer-provided photos.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper fixation of the device.

• Brand Name: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• Common Device Name: WASHER, BOLT, NUT
• 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: 19638407
• Report Number: 1220246-2024-06506
• Device Sequence Number: 15303897
• Product Code: HTN
• UDI-Device Identifier: 00888867340138
• UDI-Public: 00888867340138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• Device Catalogue Number: AR-2371BL
• Device Lot Number: 15179394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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