MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE STERNAL CLOSURE W/ CUTTING NDL; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FIBERTAPE STERNAL CLOSURE W/ CUTTING NDL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-7288 fibertape sternal closure had an issue.This was discovered during a sternal closure procedure on (b)(6) 2022.Additional information received on (b)(6) 2022: the needle attached to the fibertape broke off the suture while inside the manubrium.The needle was located and removed, it remained intact.Surgeon opened an ar-7288t tigertape sternal closure to complete the case successfully without further issues.

• Brand Name: FIBERTAPE STERNAL CLOSURE W/ CUTTING NDL
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16052051
• Report Number: 1220246-2022-05996
• Device Sequence Number: 6220046
• Product Code: GAT
• UDI-Device Identifier: 00888867369856
• UDI-Public: 00888867369856
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170206
• 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
• Report Date (Section B): 12/27/2022

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: 03/31/2026
• Device Model Number: FIBERTAPE STERNAL CLOSURE W/ CUTTING NDL
• Device Catalogue Number: AR-7288
• Device Lot Number: 13208653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 12/27/2022
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown