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 Codes	Incorrect Interpretation of Signal (1543); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).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.3: the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.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.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 or Problem Description
The healthcare professional reported that during a primary functional endoscopic sinus surgery (fess) procedure, after completing the registration and connecting the trudi navigated shaver blade (tsb4str / lot# unknown), it was noticed that the trudi navigated shaver blade accuracy was off on the trudi navigation system.The trudi navigated shaver blade was then reconnected to a different port on the instrument hub, and then the trudi navigation system displayed error 3109, navigated device error.The trudi navigated shaver blade was replaced and the issue was resolved.The procedure was resumed.There was no negative impact to the patient.On 01-jul-2024, additional information was received.The information indicated that the computed tomography (ct) image was used as the primary image.It is not known how many slices the ct scan contained.There was not more than one ct scan attempted to be used with one device.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.The patient did not move.The serial number of the trudi system is (b)(6).The trudi system software version used was 2.3.2.3.Related to the 4.0mm ¿ straight (0°) trudi navigation shaver blade (tsb4str / lot# unknown), the lot number is unknown.When the accuracy issue was observed, the bar below the device icon on the trudi system monitor was green then eventually turned red.The error message displayed on the trudi nav monitor was ¿a 3103 or something starting with the number 3¿ said navigated device error.¿ inaccuracy was determined by placing the device along known anatomical landmarks.The crosshairs did not turn yellow.The physician reported the inaccuracy up to 5 mm.The dongle used with the shaver blade was a white dongle.Based on the additional information received on 01-jul-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).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 16-jul-2024.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc-(b)(4).The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4.0mm ¿ straight (0°) trudi navigation shaver blade was received contained in a decontamination bag.Upon arrival, visual inspection was performed, and no damages nor abnormalities were observed on the device.An electrical test was performed, and the device did not meet the spec for the x-coil sensor resistance.No excess adhesive was observed between the strain relief and cable.Additionally, no wire breakage in the eeprom were observed.The device passed calibration check and met all the acceptance specifications.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The device passed visual inspection but failed electrical testing as it did not meet the specification for the sensor resistance; however, the root cause of the electrical failure that caused the error reported remains unknown.As part of acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.11.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: 19659631
• Report Number: 3005172759-2024-00073
• Device Sequence Number: 15179615
• Product Code: ERL
• UDI-Device Identifier: 10705031469235
• UDI-Public: 10705031469235
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 08/27/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/27/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/16/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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