MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI CURETTE, 0, 5IN; TRUDI CURETTE (5PK)

Model Number TDC0005

Device Problem Material Fragmentation (1261)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (201023e-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery (fess) performed in the operating room environment on (b)(6) 2021, it was reported that when the surgeon was bending the trudi curette (tdc0005 / 201023e-pc) using the bending tool, the distal end broke off.It was confirmed that the device was outside the patient¿s anatomy when the distal tip broke off.This was the first time the device was placed in the bending tool; it was not bent previously.The device had not been used in the patient.Nothing unusual was noted on the device prior to use.It was prepped and used as per the instructions for use (ifu).The trudi curette was exchanged and the surgeon completed the case with the replacement device.There was no report of any patient injury or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 26-oct-2021.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery (fess) performed in the operating room environment on (b)(6) 2021, it was reported that when the surgeon was bending the trudi curette ((b)(6)) using the bending tool, the distal end broke off.It was confirmed that the device was outside the patient¿s anatomy when the distal tip broke off.This was the first time the device was placed in the bending tool; it was not bent previously.The device had not been used in the patient.Nothing unusual was noted on the device prior to use.It was prepped and used as per the instructions for use (ifu).The trudi curette was exchanged and the surgeon completed the case with the replacement device.There was no report of any patient injury or complication.The complaint device was returned for evaluation.The investigational finding is documented below.Investigation summary: the complaint device was returned to acclarent for evaluation.Visual inspection and functional testing was performed.During visual inspection, it was observed that the trudi curette was returned with the distal tip broken off and with the shaft slightly bent.Under magnification of the microscopic inspection, it was observed that the separation of the tip was located above the weld area.The device tip and bending tool were not returned for evaluation and analysis.The complaint device was sent to the research and development (r&d) lab for further investigation.The failure was replicated using a sample trudi device.The sample trudi device was placed below the stopper of the bending tool and bent.The failure mode on the sample trudi device was then compared to the returned complaint device.Similarities were observed in the breakage of the tip, suggesting that the issue could have been related to a wrong usage of the bending tool, however, this cannot be conclusively confirmed as the bending tool was not included in the device return.A review of manufacturing documentation associated with this lot (201023e-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.However, instructions for use (ifu) cautions against bending the distal shaft more than once per angular profile.Additional bending/unbending of the distal shaft may lead to curette cup¿s embrittlement and breakage or device malfunction.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: TRUDI CURETTE, 0, 5IN
• Type of Device: TRUDI CURETTE (5PK)
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA; saret industrial park; building d3; p.o. box 74-4002; alajuala 20101 ; CS 20101
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12649283
• MDR Text Key: 276933508
• Report Number: 3005172759-2021-00013
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031465428
• UDI-Public: 10705031465428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2021
• Device Model Number: TDC0005
• Device Catalogue Number: TDC0005
• Device Lot Number: 201023E-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 10/26/2021; 11/16/2021
• Supplement Dates FDA Received: 10/26/2021; 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female