MAUDE Adverse Event Report: ARTHREX, INC. TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL; CERCLAGE, FIXATION

Model Number	TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
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 an arthrex employee via email that an ar-7289t tigertape sternal closure had one needle break as it was passed through the sternum and another needle broke free of the tigertape suture as it was being passed.All broken fragments were retrieved and case was completed using (2) ar-7289t tigertape sternal closure from the same lot number.This was discovered during a sternal closure procedure on (b)(6) 2022.
Additional Manufacturer Narrative
The complaint could not be confirmed based on the customer provided photo, no breakage is shown.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The probable cause of the event could not be determined from the information available and without device evaluation.

• Brand Name: TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
• Common Device Name: CERCLAGE, FIXATION
• 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: 14075202
• Report Number: 1220246-2022-04723
• Device Sequence Number: 4807825
• Product Code: JDQ
• UDI-Device Identifier: 00888867369887
• UDI-Public: 00888867369887
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 04/30/2026
• Device Model Number: TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
• Device Catalogue Number: AR-7289T
• Device Lot Number: 13410057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 04/25/2022
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown