MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FMS TORNADO MICRO II HAND CONTROLLED SHAVER HANDPIECE; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 283812

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/06/2023

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.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.

Event Description

It was reported by sales rep that during inspection at sterile processing of fms tornado micro ii hand controlled shaver handpiece device prior to wash and sterilization, it was observed that one of the holes circled on the side of the device had a white, hard residue filled in the hole.According to the report, the technician noticed that the residue was dry and ¿cemented"; and felt it was glue or epoxy used to seal the components.There was no procedure nor patient involvement 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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary
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> the complaint device was received at the r&d & manufacturing site and evaluated.During the analysis of the device, it was deemed that the motor presented a failure; however, as the motor cannot be disassembled to perform a repair, the devices must be discarded.The front seal of the motor is allowing saline to enter the motor during use.This causes the handpiece to stop functioning.This fault affects the reliability of the handpiece but does not adversely impact patient safety.This issue has been escalated to capa.A manufacturing record evaluation was performed for the finished device serial number: m51ab3041, and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.

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.H0 additional narrative: investigation summary; the product has not been returned to mitek for evaluation, therefore unavailable for a physical evaluation.However, 2 phots were provided.Upon visual inspection of the photo, the device has residues of an unknown white substance inside of the shaver connector hole, no further images were provided.A manufacturing record evaluation was performed for the finished device m51ab3041, and no non-conformances were identified.According with the visual inspection result, this complaint can be confirmed.Multiple factors are associated with this type of failure, the complaint device needs to be received in our service center in order to perform an evaluation.Hands on analysis will provide enough evidence to determine why the customer experienced the failure 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: FMS TORNADO MICRO II HAND CONTROLLED SHAVER HANDPIECE
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16242665
• MDR Text Key: 308917662
• Report Number: 1221934-2023-00491
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705030743
• UDI-Public: 10886705030743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 283812
• Device Catalogue Number: 283812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/07/2023; 03/06/2023
• Supplement Dates FDA Received: 02/08/2023; 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1