MAUDE Adverse Event Report: ARTHREX, INC. FIBERLINK SUTURETAPE 0.9MM WH/BL; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERLINK SUTURETAPE 0.9MM WH/BL
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Visual inspection of photographs found two different expiration dates on the labels provided.Discrepancy is the result of a split batch (#100000).No problem found.Complaint is not confirmed.
Event or Problem Description
It was reported that the customer has identified a batch number of one reference with two different expiry dates.It was noticed after the surgery.There was no harm for patient, operator or third party.No further information received.

• Brand Name: FIBERLINK SUTURETAPE 0.9MM WH/BL
• 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: 19570750
• Report Number: 1220246-2024-06224
• Device Sequence Number: 12290238
• Product Code: GAT
• UDI-Device Identifier: 00888867315259
• UDI-Public: 00888867315259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221354
• 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
• Report Date (Section B): 06/19/2024

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 Expiration Date: 01/31/2024
• Device Model Number: FIBERLINK SUTURETAPE 0.9MM WH/BL
• Device Catalogue Number: AR-7559-1
• Device Lot Number: 100000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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