• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
(b)(4). Investigation summary: the device was received and evaluated at the service center. The reported complaint that the buttons of the device do not work, was confirmed. It was found that the resistance values of the keypad were out of range. Further, it was found that the motor was corroded and does not run constantly. The motor and the hand control set were replaced and the device was repaired, tested and found to be fully functional. Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor. The corroded motor has a tendency to stick and not turn. However, given the information provided, we cannot determine a definitive root cause for the defective keypad of the hand control set. 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 04/29/2020 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. 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. Udi:(b)(4).
 
Event Description
It was reported by affiliate via phone, the micro tornado hp w handcontrol. Doesn¿t work buttons. The arthroscopic procedure was completed with a replacement device. No surgical delay. No patient consequences. The device is available to be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10631544
MDR Text Key210060894
Report Number1221934-2020-02880
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,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 Received10/05/2020
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 Manufacturer09/07/2020
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

-
-