MAUDE Adverse Event Report: DEPUY MITEK LLC US TUNNEL DILATOR, 8.0 MM; ARTHROSCOPIC DRAINAGE CANNULA

Model Number	219407
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
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 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.Additional narrative: udi: (b)(4).The expiration date is currently unavailable.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 sent.
Event or Problem Description
This is report 7 of 8 for (b)(4).It was reported by a healthcare professional that preoperatively to an unknown procedure on (b)(6) 2023, it was observed that the tunnel dilator, 8.0 mm device was contaminated upon inspection with a borescope.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was 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 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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated 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 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.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 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.H10 additional narrative: investigation summary = > the complaint device was received and evaluated.Upon visual inspection, it was noted that the device is nicked near the central canal.Also, under magnification into the center canal, evidence of contamination was observed.One of the devices reported in this complaint was sent to qa analytical laboratory for its chemical identification, mitek device was reported with unknown reddish residue in canal, infrared analysis was carried out in accordance with laboratory test method ltm-0002 rev.E "identification of materials by infrared spectroscopy" and the use of ft-ir instrument was performed in accordance with qap-0706 rev.D.Overall, infrared analysis showed that reddish material infrared peaks are associated to an inorganic salt presumably a metallic oxide.A manufacturing record evaluation was performed for the finished device lot number: 21b01, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The manufacturer performed an investigation with the following results: 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 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.Based on the visual inspection results, this complain can be confirmed.The device was manufactured in 2/8/2021 hence indicates that is more than two years old.Therefore, a possible root cause can be attributed to the storage conditions after the device was manufactured.However, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: TUNNEL DILATOR, 8.0 MM
• Common Device Name: ARTHROSCOPIC DRAINAGE CANNULA
• 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: 17129240
• Report Number: 1221934-2023-02414
• Device Sequence Number: 6487680
• Product Code: NBH
• UDI-Device Identifier: 10886705006328
• UDI-Public: 10886705006328
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• Operator of Device: Health Professional
• Device Model Number: 219407
• Device Catalogue Number: 219407
• Device Lot Number: 21B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 07/24/2023; 07/28/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 06/22/2023; 07/25/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown