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

Model Number	FIBERTAPE CERCLAGE TENSIONER, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 06-jan-2026, it was reported by a sales representative via (b)(4) that an ar-7800 fibertape cerclage tensioner had a broken tension release mechanism spring.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the spring of the fibertape cerclage tensioner, reusable was broken off and had rusted.Functional testing was performed and noted that the spring did not work as required with the lever.The most likely cause of the reported failure can be attributed to wear and tear damage incurred over repeatedly cleaning processes and extended use in the field.Manufacturing date 2017.

• 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: 24130737
• Report Number: 1220246-2026-00264
• Device Sequence Number: 10344247
• Product Code: LXH
• UDI-Device Identifier: 00888867273986
• UDI-Public: (01)00888867273986(11)170324(10)051650
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/16/2026

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: 051650
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2017
• 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