MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL INFLOW TUBING FMS VUE 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number 284508

Device Problems Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

It was reported by the affiliate in (b)(6) that during an arthroscopic rotator cuff repair on 1/5/2021, it was observed that a foreign substance was inside the package.The device in question was not used in the procedure.There was no surgical delay and no harm to the patient.The device was brand new and the first use when the issue occurred.There were no adverse patient consequences 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 mitek or its employees that the report constitutes an admission that the device, 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.

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 mitek or its employees that the report constitutes an admission that the device, 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: 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 mitek or its employees that the report constitutes an admission that the device, 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: according with the information provided, it was reported that before the nurse unsealed the inflow tubing package preoperatively, she found a brown foreign substance inside the package.The complaint device was received and evaluated.The sterile package is completely sealed.No anomalies were observed on the exterior of the device.When performing the visual inspection in the inside of the package, a brown particle of an unknown material was detected.A manufacturing record evaluation was performed for the finished device 7400 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, this complaint can be confirmed.The device was evaluated by the manufacturer with the following results: a small piece of cardboard (tappi.90) was found statically attached inside the package.This piece of cardboard was likely attached to one of the components in the kit.It is not known which piece that was.The parameters for the clean room were reviewed and found to be in conformance, there is a 100% visual inspection of the product to assure that the devices are free of any foreign matter, also there is a certification/training for all the people that manufactures the product.According with the findings previously mentioned, we can conclude that this is an isolated occurrence.An nc was opened to track this failure with the supplier (nr-0162635).A deeper investigation will perform 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: INFLOW TUBING FMS VUE 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11203030
• MDR Text Key: 227945937
• Report Number: 1221934-2021-00169
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: 10886705023066
• Combination Product (y/n): N
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2021

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 Expiration Date: 11/29/2021
• Device Model Number: 284508
• Device Catalogue Number: 284508
• Device Lot Number: 7400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 02/04/2021; 04/05/2021; 06/21/2021
• Supplement Dates FDA Received: 02/05/2021; 04/06/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1