MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS; NON-DEGRADABLE FIXATION FASTENER

Model Number	KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; no pictures were provided.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during tightening /tensioning.
Event or Problem Description
On 2/22/2023, it was reported by a sales representative via email that the inserter from an ar-2350 knotless tensiontight button implant system broke off in the button.This was discovered during a procedure on (b)(6) 2023.Additional information received on 2/22/2023: the inner threaded inserter broke off while it was being implanted.It was contained within the cannulated inserter shaft, so no fragments were in the patient.This was discovered during an rcr procedure and completed with another ar-2350 knotless tension tight button implant system.

• Brand Name: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• Common Device Name: NON-DEGRADABLE FIXATION FASTENER
• 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: 18455857
• Report Number: 1220246-2024-00157
• Device Sequence Number: 7079375
• Product Code: MBI
• UDI-Device Identifier: 00888867301924
• UDI-Public: 00888867301924
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K202444
• 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
• Report Date (Section B): 01/05/2024

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: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• Device Catalogue Number: AR-2350
• Device Lot Number: 15015483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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