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	08/12/2025
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 08/12/2025, it was reported by a sales representative via (b)(4) that an ar-7800 fibertape cerclage tensioner clavicle tensioner was cutting the sutures when releasing.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
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 user error of the device due to excessive force used during suture passing/tightening /tensioning.Ref: fibertape® cerclage system lb1-000073-en-us.1.Pay attention to the numbers on the tensioner.Don¿t tension beyond the 80 mark to avoid ¿blowing out¿ the knot.There is no recommended number to tension to.Surgeons should rely on tactile feel, as they would with cable and wire cerclage.

• 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: 22903991
• Report Number: 1220246-2025-03668
• Device Sequence Number: 8018143
• Product Code: LXH
• UDI-Device Identifier: 00888867273986
• UDI-Public: (01)00888867273986(11)211117(10)052126
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 052126
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown