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

Model Number	FIBERTAPE CERCLAGE TENSIONER, REUSABLE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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 11/25/2025, it was reported by a sales representative via (b)(4) that an ar-7800 tensioner is not functioning properly.Discovered during a case with no patient effect.Additional information 12/3: rep stated that tensioner handle was not turning appropriately and was very difficult to turn.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 wear and tear due to repeated use of the device.The device's manufacturing date is 23-dec-2019.

• 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: 23816706
• Report Number: 1220246-2025-05627
• Device Sequence Number: 21155918
• Product Code: LXH
• UDI-Device Identifier: 00888867273986
• UDI-Public: (01)00888867273986(11)191223(10)051938
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/31/2026

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: 051938
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2019
• 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