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

Model Number FIBERTAPE CERCLAGE TENSIONER, REUSABLE

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  malfunction  

Event Description

On 02/09/2024, it was reported by a sales representative via (b)(4) that an ar-7800 cerclage tensioner is fraying the suture.This occurred during use in a case with no patient effect.The surgeon had to redo the 2 cerclage cables already used to facilitate passing.Additional 15 min.Case was completed in a standard fashion.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• Type of Device: 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: 18826385
• MDR Text Key: 336924839
• Report Number: 1220246-2024-01259
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867273986
• UDI-Public: 00888867273986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• Device Catalogue Number: AR-7800
• Device Lot Number: 052144
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1