MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS TORNADO MICRO HANDPIECE WITH BUTTONS; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 283512

Device Problems Use of Device Problem (1670); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 09/20/2022

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.Additional narrative: udi: (b)(4).Reporter is a j&j employee.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.Investigation summary according to the information received, it was reported that ¿the equipment doesn't work.¿ the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: the equipment doesn't work.Per service reports, this complaint can be confirmed.The defective parts replaced to resolve the issues.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The user error was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Device history lot manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Device history batch null.Device history review null.

Event Description

It was reported by the affiliate in russia that during an unknown surgery on 9/20/2022, it was observed that the fms tornado micro handpiece with buttons device did not work.During in-house engineering evaluation, it was determined that the device had foreign debris/substance.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: FMS TORNADO MICRO HANDPIECE WITH BUTTONS
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• 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: 15597261
• MDR Text Key: 306922643
• Report Number: 1221934-2022-03120
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• 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: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1