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

Model Number	TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
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 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.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to use error.

• Brand Name: TIGERTAPE STERNAL CLOSURE W/ BLUNT 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: emily shafer ; 8009337001
• MDR Report Key: 17735566
• Report Number: 1220246-2023-07866
• Device Sequence Number: 6059844
• Product Code: JDQ
• UDI-Device Identifier: 00888867369887
• UDI-Public: 00888867369887
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 01/16/2025

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 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: 08/15/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown