MAUDE Adverse Event Report: ARTELON FLEXBAND FLEXBAND DYNAMIC MATRIX 0.3 X 8CM; MESH, SURGICAL, POLYMERIC

Catalog Number	31051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case is part of a remediation performed by stryker following the acquisition of artelon company.This case has already concluded with minimal information.Therefore, no supplemental mdr will be submitted unless additional information is provided.
Event or Problem Description
It was reported that the surgeon re-operated on a female patient 18 months after a right peroneus brevis repair.Upon reoperation the surgeon noticed the device was broken in half in the middle.The surgeon said she was doing great over a year and a half another ankle sprain likely tearing the band at that time.
Event or Problem Description
It was reported that the surgeon re-operated on a female patient 18 months after a right peroneus brevis repair.Upon reoperation the surgeon noticed the device was broken in half in the middle.The surgeon said she was doing great over a year and a half another ankle sprain likely tearing the band at that time.
Additional Manufacturer Narrative
Correction to d4(gtin).This investigation is part of the artelon remediation aiming to transfer the data history into tw.An investigation of this case has already been performed by artelon.The conclusion of the investigation states, "not reportable.Reoperation was not a result of band breaking.Surgeon realized band was broken once patient was opened for pre-planned surgery.".

• Brand Name: FLEXBAND FLEXBAND DYNAMIC MATRIX 0.3 X 8CM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ARTELON; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer (Section G): ARTELON; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20946899
• Report Number: 3010673515-2024-00024
• Device Sequence Number: 4513654
• Product Code: FTL
• UDI-Device Identifier: 00868047000335
• UDI-Public: (01)00868047000335(17)240831
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K230316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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?: Yes
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 31051
• Device Lot Number: A1907001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown