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

Model Number	TIGERTAPE STERNAL CLOSURE W/ CUTTING NDL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/20/2024, it was reported by a sales representative via email that seven ar-7288t fibertape sternal closure appeared loose and unraveled.The surgeon attempted to use them; however, they tore an inch or two behind the needle.This was discovered during a procedure on (b)(6) 2024.Additional information received on 7/1/2024: this was discovered during a cabg procedure.The case was completed by replacing all the ar-7288t fibertape sternal closure with ar-7288 fibertape sternal closure.Everything was removed from the patient and the case was delayed between two to three minutes.The sales representative does not know if additional anesthesia was administered.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.1 unpackaged, and two sealed, ar-7288t, batch 15198180, were received for evaluation.Visual inspection noted that the seal of one box was broken, but the other two were intact.Functional testing revealed that the assembly of the needle of the tigertape¿ sternal closure was placed incorrectly according to drawing c20810.The most likely cause for the reported failure can be attributed to a manufacturing issue.

• Brand Name: TIGERTAPE STERNAL CLOSURE W/ CUTTING NDL
• Common Device Name: FIXATION CERCLAGE
• 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: 19729965
• Report Number: 1220246-2024-06720
• Device Sequence Number: 8147849
• Product Code: GAT
• UDI-Device Identifier: 00888867369863
• UDI-Public: 00888867369863
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K232755
• 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,Followup
• Report Date (Section B): 10/01/2024

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 Model Number: TIGERTAPE STERNAL CLOSURE W/ CUTTING NDL
• Device Catalogue Number: AR-7288T
• Device Lot Number: 15198180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2024
• 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