MAUDE Adverse Event Report: ARTHREX, INC. RADIOPAQUE FT STERNAL W/CUTTING NDL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	RADIOPAQUE FT STERNAL W/CUTTING NDL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
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
On (b)(6) 2024, a sales representative reported via phone and email that qty.4 of an ar-7288r radiopaque ft sternal w/cutting ndl had an issue before use in an upcoming procedure scheduled later that day and had expired.An additional email was received from the sales representative, providing additional information after three of the expired ar-7288r radiopaque ft sternal w/cutting ndl had been used in a cabg procedure on (b)(6) 2024.When the first implant was opened, the needle had pulled off the sutures before use, so another ar-7288r was opened.Upon checking, it was noticed that all four ar-7288r had expired.The sales representative informed the surgeon and the nurses of the expired product and that he believed it to be an error with the labeling.The surgeon and nurses understood, and three ar-7288r sternal closures and two ar-7289r sternal closures were successfully implanted.Later that day, the director of the facility requested paperwork confirming that these products were mislabeled.Additionally, it was noted that a disposable tensioner was also used, and they had a few issues getting the right friction to apply on the tapes around the square, but adequate tension was applied, and the sternum was approximated very well.This occurred before and during use with no patient harm.Additional information has been requested.On (b)(6) 2024, the sales representative stated via email that the ar-7288r radiopaque ft sternal w/cutting ndl where the needle had pulled off the sutures and the ar-7820 disposable cerclage tensioner were discarded after the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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 excessive force used during suture passing/tightening /tensioning.

• Brand Name: RADIOPAQUE FT STERNAL W/CUTTING NDL
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19739681
• Report Number: 1220246-2024-06732
• Device Sequence Number: 3654039
• Product Code: GAT
• UDI-Device Identifier: 00888867392038
• UDI-Public: 00888867392038
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K230976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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 Expiration Date: 05/31/2024
• Device Model Number: RADIOPAQUE FT STERNAL W/CUTTING NDL
• Device Catalogue Number: AR-7288R
• Device Lot Number: 15110899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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