MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SHAVER BLADE - STRAIGHT, DOUBLE SERRATED, 4.0MM X 110MM; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	TSB4STR
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a revision bilateral functional endoscopic sinus surgery (fess) procedure on (b)(6) 2024, accuracy was reported to be off on the trudi system and shifted to the left side of the patient.The two suction devices: 0° trudi nav suction device (tdns000z / lot# unknown) and 70° trudi nav suction device (tdns070z / lot# unknown), and the 4.0mm ¿ straight (0°) trudi navigation shaver blade (tsb4str / lot# unknown) had accuracy issues.No troubleshooting was performed.The procedure continued without resolution.There was no report of any negative patient impact.On 14-may-2024, additional information was received.Per the additional information, accuracy was confirmed using the registration probe after the registration was completed.The end user confirmed accuracy using known landmarks in endoscopic visualization inside the nasal cavity.Accuracy was determined by checking on known landmarks.The inaccuracy was first noticed when checking in the sphenoid wall.Accuracy was validated using both the registration probe and through instrumentation.Computed tomography (ct) image was used as the primary image.The ct scan contained 100+ slices.The field of view was axial.There were no noticeable defects to the ct scanned images.The physician performed the registration process.The information indicated that the physician had performed ¿1000s¿ of registrations.The information indicated that accuracy was confirmed on the maxillary wall and sphenoid wall.The serial number of the trudi system is 100121; software version is 2.3.3.There was no potential for metal interference.The registration process was not restarted / redone after the initial finding.The patient tracker did not move.The patient tracker cable was not under tension in relation to this event.There was no ferromagnetic material placed within the trudi zone.The emitter pad did not move and the patient did not move.No other device shaft was in the proximity to the transmitter of the emitter pad.On 20-may-2024, additional information was received related to the devices.Related to the 4.0mm ¿ straight (0°) trudi navigation shaver blade (tsb4str / lot# unknown), when the accuracy issue was observed, the bar below the device icon on the trudi system monitor was green.There was no error message on the trudi nav monitor for this device.Inaccuracy was determined after the device was plugged in after registration.Inaccuracy was determined when testing inside the nose.The crosshairs did not turn yellow.The inaccuracy was not within 2mm.The serial number marked on the white trudi connector (usb) cannot be obtained.The dongle used with the shaver blade was a white dongle.The lot number of the shaver blade device is not available.Based on the additional information received on 20-may-2024, the issues reported have been determined to be usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, 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 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 is 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 product 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 - STRAIGHT, DOUBLE SERRATED, 4.0MM X 110MM
• 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: 19375205
• Report Number: 3005172759-2024-00063
• Device Sequence Number: 12667403
• Product Code: ERL
• UDI-Device Identifier: 10705031469235
• UDI-Public: 10705031469235
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/22/2024

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: TSB4STR
• 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: 05/20/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown