MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI CURETTE, 0, 5IN; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number TDC0005

Device Problem Fracture (1260)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The initial reporter phone and email address are not available.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.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 the physician broke the tip of the trudi curette (tdc0005 / 201023e-pc) when he was bending it outside the patient¿s anatomy.The physician never used the trudi curette in the patient after he broke off the tip trying to bend it with his fingers.There was no patient adverse event.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 01/22/2021.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 the physician broke the tip of the trudi curette (tdc0005/201023e-pc) when he was bending it outside the patient¿s anatomy.The physician never used the trudi curette in the patient after he broke off the tip trying to bend it with his fingers.There was no patient adverse event.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the complaint device was received at the product analysis lab after decontamination.The device underwent visual inspection and was observed bent at approximately 1cm from the distal end.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.The complaint reported that the physician was bending the trudi curette outside the patient¿s anatomy when the distal tip broke as the physician was trying to bend it with his fingers.The reported issue was confirmed based on the visual inspection performed on the returned device.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the overall condition of the device.Thus, it is not likely that the trudi curette left the manufacturing facility with the distal tip bent at approximately 1cm from the distal end as noted during the visual inspection performed on the returned complaint device.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 that a re-review of the additional event information received on 22 december 2020 was performed on 27 april 2021.The reportability of the file was also reassessed.Based on the information provided on 22 december 2020, which stated the following: ¿there was no patient problems.The doctor broke the tip of the curette when he was bending it outside the patient¿s nose.He never used it in the patient after he broke off the tip trying to bend it with his fingers.¿ as per the instructions for use (ifu), ¿trudi® curette shall only be used with the provided bending tool as shown in ¿instructions for use¿ section for bending and unbending the distal shaft.¿ and ¿prying, excessive force or misuse may result in the breakage or failure of the trudi® curette resulting in possible harm to patient or user.¿ with this information, the file no longer meets the medical device reporting criteria as a malfunction.Therefore, it has been deemed not reportable.No further reports will be forthcoming.

• Brand Name: TRUDI CURETTE, 0, 5IN
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• MDR Report Key: 11127984
• MDR Text Key: 241660990
• Report Number: 3005172759-2020-00008
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031465428
• UDI-Public: 10705031465428
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2020

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: 01/22/2021
• Initial Date Manufacturer Received: 12/19/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/22/2021; 02/08/2021; 04/27/2021
• Supplement Dates FDA Received: 01/22/2021; 02/08/2021; 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1