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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM Back to Search Results
Model Number 283512
Device Problem Corroded (1131)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: the complaint device was received at the service center and evaluated. An article defect was reported, defects were found with the device during evaluation; therefore, this complaint can be confirmed. It was observed during evaluation that the motor was corroded and stuck. The values of the keypad of the hand control were out of range and the buttons did not function. The motor and hand control set were replaced to resolve the issues. After repair, the device was found to be working according to the specifications. Fluid ingress into the device and contact with the motor is responsible for the rusty motor. Corroded motor has a tendency to stick and not turn. With the available information, we cannot determine the root cause of the defective hand control. The corroded motor and defective hand control would have caused the customer to experience the reported problem. The service history has been reviewed in lieu of the device history record for this device since it was previously serviced. The device was last serviced on 11/22/2019 and passed all functional testing before being returned to the customer. 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. Udi: (b)(4).
 
Event Description
It was reported via affiliate the micro tornado hp w hand control had an article defect.
 
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Brand NameMICRO TORNADO HP W HANDCONTROL
Type of DeviceLINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10848567
MDR Text Key217338280
Report Number1221934-2020-03507
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283512
Device Catalogue Number283512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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