MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SHAVER BLADE 4.0MM - 15° CURVED - 1PK; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	TSB415Z
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that on 01-feb-2024, during a primary hybrid functional endoscopic sinus surgery (fess) procedure, when the 4.0mm ¿ 15° trudi navigation shaver blade (tsb415z / lot# unknown) was tracking on the trudi navigation system (fg200000 / s/n: (b)(6), software version 2.3.2, ¿it would jump to show the standard ct scan then it would jump to show like it was tracking again.¿ the connections for the trudi shaver blade was reseated again with no resolution.It was reported that they were able to continue the procedure using the trudi shaver blade.The device is not available for return.It was also reported that the trudi navigation system displayed an error (code unknown) that indicated that the 0° trudi nav suction device (tdns000z / 2112140) needed to be replaced.The bar below the device icon on the trudi system monitor was red.The 0° trudi nav suction device was replaced and the issue resolved.The device is not available for return.There was no negative patient impact reported.On 09-feb-2024, limited additional information was received pertaining only to the trudi shaver blade.Per the additional information received, the lot number of the trudi shaver blade is not available.The device problem related to the trudi shaver blade was due to visual issue.There was no error code on the trudi nav monitor for the device.The dongle used was the white dongle.No additional information was provided for the trudi suction device.Based on the additional information received on 09-feb-2024, related to the trudi shaver blade, the event has been deemed reportable as a "malfunction.".
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d:2b: procode is pgw/erl.Section d.4: the expiration date of the device is not known as the device lot number is not available: not reported.Section e.1: the initial reporter phone is not available: reported.Section h.4: the device manufacture date is not known as the device lot number is not available : not reported.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 803.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.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.

• Brand Name: TRUDI SHAVER BLADE 4.0MM - 15° CURVED - 1PK
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA; saret industrial park building; rio segundo; alajuela 90109 ; CS 90109
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 18691419
• Report Number: 3005172759-2024-00012
• Device Sequence Number: 15543114
• Product Code: ERL
• UDI-Device Identifier: 10705031469297
• UDI-Public: 10705031469297
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K221037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2024

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 Catalogue Number: TSB415Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRUDI SUCTION, 0 - 1PK
• Patient Sex: Unknown