MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR 8.5MM *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number	219408
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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.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.
Event or Problem Description
It was reported that the tunnel dilator 6.5mm device had rust and metal shavings inside, the tunnel dilator 7.0mm device had rust inside, the tunnel dilator 8.5mm device had rust and metal shavings inside, the tunnel dilator 9.5mm device had rust and metal shavings inside, the tunnel dilator 10.0mm device had rust and metal shavings inside, the tunnel dilator 10.5mm device had rust inside, the tunnel dilator 11.0mm device had rust and metal shavings inside, the tunnel dilator 11.5mm device had rust inside, and the tunnel dilator 12.0mm device had rust inside.It was not reported if the devices was used in a surgical procedure.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported; however, it was reported that the event occurred in 2026.All available information has been disclosed.No additional information could be provided.This is report 2 of 5 for (b)(4).

• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25086672
• Report Number: 1221934-2026-01934
• Device Sequence Number: 13364357
• Product Code: NBH
• UDI-Device Identifier: 10886705006335
• UDI-Public: (01)10886705006335(10)21R01
• 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

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: 219408
• Device Lot Number: 21R01
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2021
• 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