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 01/12/2022

Event Type  malfunction  

Event Description

It was reported by the sales rep in australia that preoperatively to an unknown surgery on (b)(6) 2022, it was observed that a hair was inside the packaging of the 5 mm ultra aggressive plus device upon opening.Another like device was used to complete the procedure.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.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.

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 is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, the device's tip is shown, a black particle near the distal tip of the blade can be observed through the transparent blister.A manufacturing record evaluation was performed for the finished device m2110009 number, 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 can be confirmed.Multiple factors are associated with this type of failure, the complaint device needs to be evaluated by the manufacturer.Hands on analysis will provide enough evidence to determine a root cause.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.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 follo-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : the complaint device was received for evaluation.The device is inside in a completely sealed blister, there is a 5mm semi-circle shaped black particle inside the blister, the blister was unsealed to get the black particle and verify the material.The object was sent to the qa analytical laboratory for its chemical identification.Infrared analysis was carried out in accordance with laboratory test method ltm-0002 revision e "identification of materials by infrared spectroscopy" and the use of ff-ir instrument was performed in accordance with qap-0706 rev.D.It can be seen that the foreign material and connector section exhibits the same material characteristics of polyetherimide (pei).In the functional group region, peaks corresponding to ch asymmetric and symmetric vibrations can be observed at 2968 and 2933 cm overall, infrared spectroscopy results revealed that the foreign material exhibits the same material characteristics of polyetherimide (pei), which when compared to the connector material of the device, it shares the same molecular vibrations.Connector material is pinpointed as the source of origin.A manufacturing record evaluation was performed for the finished device m2110009, 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 result, this complaint can be confirmed.The fibers are generated during the induction welding process of the (black ultem) hubs to the (s.S.) tubes.The induction welding process generates flash that can become loose from the hub and then turn into the loose black ultem fiber.The supplier should be inspecting and removing the flash / fibers post the welding operation.An nc was opened to track this failure with the supplier so that a deeper investigation will be performed under this action.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: 15133678
• MDR Text Key: 303166796
• Report Number: 1221934-2022-02261
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022083
• UDI-Public: 10886705022083
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 283729
• Device Catalogue Number: 283729
• Device Lot Number: M2110009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/05/2022; 09/25/2022; 09/29/2022
• Supplement Dates FDA Received: 08/08/2022; 09/26/2022; 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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