MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR 7.5MM *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number	219406
Medical Device Problem Codes	Degraded (1153); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the newly received tunnel dilator 7.5mm device contained a significant amount of metal shavings and rust inside the inner cannula, as confirmed by a boroscope examination.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11: additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device was able to confirm the reported event, the cannula inner surface was found, at one side, with delaminated patterns and, at the other side of the shaft/cannula, with brownish matter or debris.It is not unreasonable that the condition identified in visual analysis would contribute to a corrosion/oxidation condition.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the tunnel dilator 7.5mm *ea would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to procedural variables, such as a product interaction during the cleaning, sterilization and maintenance process.As per instructions for use (ifu), the following precautions are stated: 1) clean instruments as soon as possible after use; 2) if cleaning must be delayed, wet the instruments in a compatible liquid solution to prevent drying and encrustation of surgical soil; 3) remove excessive soil with a disposable wipe; 4) prior to sterilization, instruments should be cleaned by either automated or manual process, using a ph neutral detergent; 5) when cleaning instruments with cannulations or lumens (i.E.Tubes), or holes, use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub the cannula, lumen, or hole.Push in and out, using a twisting motion to remove debris; and 6), use a syringe filled with enzymatic cleaning solution to flush hard to reach internal areas.Properly handling and attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11: additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 22099716
• Report Number: 1221934-2025-01947
• Device Sequence Number: 12623882
• Product Code: NBH
• UDI-Device Identifier: 10886705006311
• UDI-Public: (01)10886705006311(10)20D01
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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: 219406
• Device Lot Number: 20D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 06/10/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/06/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown