MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR 9.0MM *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number	219409
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.(b)(4).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 from the sales rep on an unspecified date that the tunnel dilator 6.5mm *ea devices (x6) dilator had contaminants (rust and metal shavings) in the cannulated sleeve of the instrument.This event did not occur during surgery.All available information has been disclosed.This is report 2 of 6 for (b)(4).
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.H10 additional narrative: investigation summary the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number 21r01, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: investigation summary: the product was returned to depuy synthes mitek for evaluation.Depuy synthes mitek then conducted visual inspection of the device received.The device was returned without its original packaging.Upon visual inspection, the device has no structural anomalies or damages.Under magnification into the center canal, evidence of rust was found on the proximal end.The overall complaint was confirmed as the observed condition of the tunnel dilator 9.0mm *ea would have contributed to the complained issue.The manufacturer performed a previous investigation related to same issue, with the following result: before the packaging process a hutter (brush) is used to clean the hole of each device, then perform an ultra sonic bath cleaning to these products.Tag performs a 100% visual inspection for defects including rust during product release, it also consists in detect mechanical defects, visible scratches, and burrs.The external factors that could have caused the reported issue as per the instructions for use; stating that the products must be stored in a manner to protect from dust, moisture, insects, vermin and extreme of temperature and humidity.These products should be subjected to room temperature.To the information provided and as to our estimate, these products were not stored as to the ifu requirements, the condition of these tunnel dilators products with different lot numbers and manufactured at different times and years have the same problem of rust which can be related an improper storage.The device was manufactured in 12/05/2021 hence indicates that is more than two years old.Therefore, the potential root cause can be attributed to the storage conditions after the device was manufactured.Therefore 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 depuy synthes mitek 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 review: a manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.

• 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: 18747711
• Report Number: 1221934-2024-00534
• Device Sequence Number: 14412288
• Product Code: NBH
• UDI-Device Identifier: 10886705006342
• UDI-Public: 10886705006342
• 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,Followup
• Report Date (Section B): 02/21/2024

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: 219409
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 03/04/2024; 05/23/2024; 06/07/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/04/2024; 05/29/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown