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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 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: the complaint device was received at the service center and evaluated. The sales rep reported an issue of the device gave an error code 15. Per service manual operational and diagnostic, this complaint can be confirmed. It was found during evaluation that the motor, and cable of the device were defective. Corrosion and physical damages were also observed. The corroded and damaged components along with the motor were replaced to resolve the issues. Preventive maintenance was also carried out. After repair, the device was found to be working according to the specifications. Fluid contact is responsible for the corrosion observed. User mishandling and/or lack of maintenance can be the most probable root causes of the physical damages. With the available information, we cannot determine the root cause of the other identified failures. The faulty components would have caused the device to give the reported error code. A manufacturing record evaluation was performed for the finished device serial number (1921m4715r), and no non-conformance was identified. 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 by the sales rep via phone that before an unknown procedure, and during testing of the fms tornado micro handpiece with buttons an error code 15 appeared. The sales rep tried to troubleshoot the device by plugging, and unplugging it, but it was not solved. Another device was used to complete the procedure. The device is available to be returned for evaluation.
 
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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 Key10607869
MDR Text Key209232409
Report Number1221934-2020-02813
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 09/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
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 Manufacturer09/08/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
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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