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

Model Number FIBERTAPE CERCLAGE TENSIONER, REUSABLE

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

On 08/04/2023, it was reported by a sales representative via sems that an ar-7800 fibertape cerclage tensioner, reusable had an issue during a cabg procedure on (b)(6) 2023.The surgeon had complained that the new device had been cutting the fibertape before final tensioning.No piece broke off inside the patient, and the procedure was completed successfully.This occurred during use with no patient harm.Additional information has been requested.On 8/21/2023, the sales representative provided the following information via email: this malfunction occurred with 2 fibertapes, but he could not provide part and lot numbers as he was not covering that case.All fibertapes were removed and discarded.The procedure was completed with the same ar-7800 fibertape cerclage tensioner, reusable, and a new fibertape with an unknown part and lot number.There was a small case delay of maybe 5 minutes reported, and no additional anesthesia was administered to the patient.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Manufacturer Narrative

Additional information: h6 complaint is not confirmed.The returned device was visually inspected and did not have any issues.Functional test with 2 fibertape did not find any problem, and no issues were found with the fibertape.The ratcheting function did not have any issues.No problem found.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17666444
• MDR Text Key: 322481324
• Report Number: 1220246-2023-07753
• 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,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1