MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE CERCLAGE TENSIONER, REUSABLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	FIBERTAPE CERCLAGE TENSIONER, REUSABLE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a sales representative reported via (b)(4) that an ar-7800 fibertape® cerclage tensioner was malfunctioning; they were having to hold the side bolt in order for the pin to catch the gear so it would hold tension.This occurred during a case.Additional information was provided on (b)(6) 2026 where the sales representative reported via (b)(4) that this event occurred during a cabg procedure.Fibertape cerclage was used to complete the procedure.There was no delay or additional anesthesia administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d4, d9, g3, h3, h6.Complaint allegation is confirmed.Visual evaluation noted that the lever spring, ratchet gear, ratchet shaft and cap screw were broken off from the fibertape cerclage tensioner, reusable, and not returned.Functional testing was not performed due to the broken/damage condition to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device, like dropping the device.

• Brand Name: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24857453
• Report Number: 1220246-2026-02168
• Device Sequence Number: 10549260
• Product Code: LXH
• UDI-Device Identifier: 00888867273986
• UDI-Public: (01)00888867273986(11)250501(10)052504
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/06/2026

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: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• Device Catalogue Number: AR-7800
• Device Lot Number: 052409
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown