MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II BTB, RECON IB¿; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE® II BTB, RECON IB¿
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/3/2024, it was reported by a facility representative via email that an ar-1588btb-ib tightrope ii btb would not pass smoothly at all after it was passed through the bone block, the loop, and then the wire loop to pass through the tightrope mechanism.The wire ended up breaking, so a second tightrope was opened.Following the same steps, the second ar-1588btb-ib tightrope ii btb passed with ease through the mechanism, and the case was completed.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 10/15/2024: this was discovered on the back table during an acl reconstruction procedure.The case was delayed approximately five minutes to get a new ar-1588btb-ib tightrope ii btb; additional anesthesia was not needed.
Additional Manufacturer Narrative
Correction: h1 to n/a.Additional information: b5.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• Brand Name: TIGHTROPE® II BTB, RECON IB¿
• Common Device Name: NON-DEGRADABLE FIXATN 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: jared engle ; 8009337001
• MDR Report Key: 20428697
• Report Number: 1220246-2024-08107
• Device Sequence Number: 8402497
• Product Code: MBI
• UDI-Device Identifier: 00888867319677
• UDI-Public: (01)00888867319677(11)240115(17)281231(10)15193452
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: TIGHTROPE® II BTB, RECON IB¿
• Device Catalogue Number: AR-1588BTB-IB
• Device Lot Number: 15193452
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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