MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR 10.5MM *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 219412

Device Problems Degraded (1153); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

This is report 2 of 5 for (b)(4).It was reported that during inspection with a boroscope, it was observed that the tunnel dilator 9.0mm device had rust and metal shavings in them even with being brand new.This event did not occur during surgery.No additional information was provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).The device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be submitted accordingly.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 medwtch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Investigation summary : photos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos.Visual inspection reveled that the five tunnel dilators appear to be in used condition, they also have marks of possible rust, also three unknown source fibers can be noted in four of the devices.Hands on analysis should provide the require evidence to confirm the oxidation and a possible root cause.The overall complaint was confirmed as the observed conditions of the tunnel dilators would contribute to the complained devices issue.The manufacturer performed a previous investigation related to same issue, the results were the following: before the packaging process a hutter is used to clean the hole of each device, then perform a 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 ifu-109284 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 2/29/2020 hence indicates that is more than four 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 20a02, and no non-conformances were identified.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 depuy synthes mitek for evaluation.Depuy synthes mitek then conducted visual inspection of the device received.The complaint device was received without its packaging and in used condition, it was evaluated.Upon visual inspection, the device has no structural anomalies.Under magnification into the center canal, evidence of rust was identified.The overall complaint was confirmed as the observed condition of the tunnel dilator 10.5mm *ea would have contributed to the complained issue.The manufacturer performed a previous investigation related to same issue, the results were the following: before the packaging process a shutter is used to clean the hole of each device, then perform a 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 ifu: 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 2/29/2020 hence indicates that is more than four 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 20a02, and no non-conformances were identified.

• Type of Device: 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: 19186464
• MDR Text Key: 341419556
• Report Number: 1221934-2024-01381
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705006373
• UDI-Public: 10886705006373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• Device Operator: Health Professional
• Device Catalogue Number: 219412
• Device Lot Number: 20A02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 04/30/2024; 05/03/2024
• Supplement Dates FDA Received: 05/01/2024; 05/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1