MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK; ARTHROSCOPE

Catalog Number	283429
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the ultra aggressive plus 4.0mm device had a foreign substance in the packaging (fmip-inorganic).This event did not occur during surgery.There were no adverse consequences to the patient.The exact date of the event was not reported, however, it was reported that the event occurred in 2025.No additional information could be provided.
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: investigation summary: the product has not returned to j&j medtech orthopaedics, however photos were provided for evaluation.Visual inspection of the returned photos found a particle on the packaging tray.No other anomalies were noted.The manufacturer performed an investigation of the photos with the following results: walking process was performed in depuy manufacturing line and the below conditions were found: 1.The plastic components (hubs and rings) were received with loose particles 2.The nests of the induction welder machine were found with the loose particles.3.Containers (bins) with subassemblies in manufacturing line were found with loose particles.4.Grease application workstation was found with loose particle in the nest when the subassemblies were placed.5.Cleaning frequency is not proper followed as it is stated in the procedure.No corrections are taken since none of the parts were returned.Supplier open internal capa to perform a deep analysis to find the potential causes and determine the corrective / preventive actions.The overall complaint was confirmed as the observed condition of the ultra aggressive plus 4.0mm 5pk would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the photos received and possible cause cannot be established.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.Device history lot: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance was identified.

• Brand Name: ULTRA AGGRESSIVE PLUS 4.0MM 5PK
• Common Device Name: ARTHROSCOPE
• 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: 22185452
• Report Number: 1221934-2025-02155
• Device Sequence Number: 20933027
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: (01)10886705022229(10)M2501001(17)291231
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K131191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,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: 283429
• Device Lot Number: M2501001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown