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	Chest Pain (1776)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
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 09/07/2021, it was reported through the clindex system that on (b)(6) 2021 a patient presented to the ed with intermittent, moderate, left chest pain.The patient underwent an initial procedure on (b)(6) 2021 were fibertape sternal closure was used.No additional information provided.Additional information requested.Additional information provided 09/08/2021: the patient did not have a procedure on (b)(6) 2021, the pi determined relatedness on (b)(6) 2021.The initial procedure was on (b)(6) 2021.The arthrex device used during the procedure are as follows: ar-7297, lot: 12532894, qty.4.No revision necessary.

• 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
• MDR Report Key: 12540091
• Report Number: 1220246-2021-03699
• Device Sequence Number: 17435582
• Product Code: GAT
• UDI-Device Identifier: 00888867369856
• UDI-Public: 00888867369856
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: FIBERTAPE STERNAL CLOSURE W/ CUTTING NDL
• Device Catalogue Number: AR-7288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other