MAUDE Adverse Event Report: DEPUY MITEK LLC US 4 MM ULTRA AGGRESSIVE PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283429

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Event Description

It was reported by the sales rep in sweden that during an unknown procedure on an unknown date, a 4 mm ultra aggressive plus device was used.According to the report, there was it was observed that the device was too much lubricant on the top of the device.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.Additional narrative: udi: (b)(4).Reporter is a j&j sales representative.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.

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.D9, h3, h6: 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.

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: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual inspection reveled that the device shows grease in the tip, structural anomalies could not be identified.No further information was provided.A manufacturing record evaluation was performed for the finished device m2205031, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, this complaint was not confirmed.According with the manufacturer procedure; 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.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.

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 product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The complaint device was received and evaluated.Visual inspection reveled that the device tip shows grease inside the inner hub, the outer hub as well as the outer hub black connector were in a normal shape, the inner hub was removed from the outer hub and it does not show structural anomalies as well as the inner hub black connector.To test its functionality, the device was inserted into a test shaver handpiece, no restriction was noticed when connected, the shaver hand piece was turned on and the blade worked as expected.A manufacturing record evaluation was performed for the finished device m2205031, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, this complaint was not confirmed.According with the manufacturer procedure; 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.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: 4 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: 16977126
• MDR Text Key: 316224101
• Report Number: 1221934-2023-02061
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: 10886705022229
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 283429
• Device Catalogue Number: 283429
• Device Lot Number: M2205031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/03/2023; 06/13/2023; 06/16/2023
• Supplement Dates FDA Received: 06/06/2023; 06/14/2023; 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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