MAUDE Adverse Event Report: DEPUY MITEK LLC US 5 MM ULTRA AGGRESSIVE PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283729

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/12/2023

Event Type  malfunction  

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.Udi: (b)(4).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 Description

This is report 3 of 3 for (b)(4).It was reported by a healthcare professional in france that preoperatively to an unknown procedure on (b)(6) 2023, it was observed that there was a presence of a big quantity of white liquid (lubricant) inside the packaging of the 5 mm ultra aggressive plus device.According to the report, the opened a second one but it had the same issue.It was further reported that they opened a third one but no more presence of white liquid in such an important way.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.

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.Investigation summary : the complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation, however a photo was provided.Visual inspection reveled that only one device is shown in the photo, also, the device is shown in its original packaging, grease could be seen in the device tip.A manufacturing record evaluation was performed for the finished device m2206021, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint cannot be confirmed.The manufacturer performed an investigation with the photo provided by the customer with the following results: the unit present grease in the tip, because is part of the manufacturing process, the unit have two application of grease , one is in the inner tube and then assembled in the outer tube, then the second application of grease is in the tip.This is part of the manufacturing process.According to the 8089.Ewi step 2 (place the efd tip inside the opening without touching the interior of wall the grease).Then part of packaging process 8035.Ewi is the clean of the excess of grease.No corrective action is required because the application is part of the manufacturing process, and the process have 100% of visual inspection and the aql = 0.65.Based on the preliminary investigation the grease found in the unit is part of the manufacturing process, the device presented grease inside the inner tube and the tip, that is validated process.Based on this, it can be considered as no integer defect, since the product per requirements need to have grease inside the tip.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: 5 MM ULTRA AGGRESSIVE PLUS
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• 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: 16816320
• MDR Text Key: 314022639
• Report Number: 1221934-2023-01832
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022083
• UDI-Public: 10886705022083
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• 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
• Device Operator: Health Professional
• Device Model Number: 283729
• Device Catalogue Number: 283729
• Device Lot Number: M2206021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 06/24/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1