MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHROSCOPY EQUIPMENT CART; ELECTROMECHANICAL DEVICE TRANSPORT TROLLEY

Catalog Number 281406

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The serial number was unknown.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 after a lumbar fusion surgery on an unknown date, it was observed that there was rust on the arthroscopy equipment cart device.There was no delay in the procedure.The procedure was completed with the same device was it did not affect the outcome of the surgery.There was an alternative product readily available but was not necessary.There was no surgical or medical intervention.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.Investigation summary
=
> according to the information provided, it was reported that rust on the arthroscopy equipment cart.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 devices were presented signs of corrosion and coating peeling in several areas.The complaint reported was confirmed.The photo do not provide enough evidence to determine root cause.The possible root cause for the reported failure can be attributed to fair wear and tear of the device or can be associated to the deterioration of the metal between it and the surrounding environment.This cannot be conclusive determined.Given that lot number was not provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: ARTHROSCOPY EQUIPMENT CART
• Type of Device: ELECTROMECHANICAL DEVICE TRANSPORT TROLLEY
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10829822
• MDR Text Key: 217726577
• Report Number: 1221934-2020-03442
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 281406
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1