MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 283512

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (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.Udi: (b)(4).The serial number is unknown at this time.

Event Description

It was reported by affiliate that during a rotator cuff repair, an operation room nurse wanted to connect the shaver blade to a fms tornado micro ii hand controlled shaver handpiece, but could not connect it.A red rubber inside the handpiece was not in the right position and blocked the shaver disposable.No surgical delay, or patient consequences reported.Additional information received from the affiliate reported, "red o ring inside the hp 2.0 is not in the normal position.Red o ring inside the hp is very dry.Red o ring on handpiece cable connector is very dry and have a black stripe and big internal crack.This new handpiece has passed the sterilization procedure also 4 times." additional information reported by the affiliate stated the case was completed with a readily available device.

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.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.Investigation summary: according to the information provided, it was reported by affiliate that during a rotator cuff repair, an operation room nurse wanted to connect the shaver blade to a fms tornado micro ii hand controlled shaver handpiece but could not connect it.A red rubber inside the handpiece was not in the right position and blocked the shaver disposable.The device was sent to the manufacturer from the netherlands to kimball poland to be analyzed.According with information received by the manufacturer the red o-ring was not in the normal position.No additional anomalies were observed.No cracks nor defects found on fisher connector o-ring.The complaint can be confirmed.The o-ring was correctly placed inside handpiece.In other hand, the handpiece was tested under seal verification and verification of the blade locking mechanism test.As result, both test were satisfactory.Besides, the blade was inserted and removed 15 times.After each trial o-ring condition was verified and no anomalies were found and o-ring is correctly placed in the inner groove of the handpiece head.As conclusion emitted by manufacturer, the problem could occur during improper blade inserting.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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: MICRO TORNADO HP W HANDCONTROL
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10657359
• MDR Text Key: 210690699
• Report Number: 1221934-2020-02943
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 12/16/2020
• Date Manufacturer Received: 12/19/2020
• Removal/Correction Number: N/A
• Patient Sequence Number: 1