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

Model Number TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL

Device Problem Material Frayed (1262)

Patient Problem Failure of Implant (1924)

Event Date 08/14/2023

Event Type  Injury  

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 Description

On 08/15/2023, it was reported by a sales representative via sems that qty.4 of an ar-7289t tigertape sternal closure with attached blunt tapered needle had an issue.The tapes were frayed at the tip of the tensioner to the point that there was only one strand of suture left.They were not able to tie a know to hold tension.The tensioner did not go past the 80 line.The tapes were removed, the patient's health was not compromised.The devices were discarded after the case, and no pictures were taken.Additional information has been requested.On 8/21/2023, the sales representative provided the following additional information via email: this occurred during a sternal closure cerclage procedure on (b)(6) 2023.Two ar-7800 fibertape cerclage tensioner, reusable did not got past the 80 line, one device with lot number 051912 and one device with lot number 051650.No pieces of the tensioners broke, but the fibertape tail that sits in the top slot of the tensioner.All fragments of the fibertapes were removed.The case was completed by pulling the fibertapes out and using wires and plates to close.There was no adverse effect to the patient reported and no case delay.

• Brand Name: TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17735566
• MDR Text Key: 323266322
• Report Number: 1220246-2023-07866
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 00888867369887
• UDI-Public: 00888867369887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
• Device Catalogue Number: AR-7289T
• Device Lot Number: 13410057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2023
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other