• 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 Electrical Shorting (2926)
Patient Problem Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). Investigation summary: the device was received and evaluated at the service center. The reported complaint that the hand piece wasn't recognized by the pump and that there was a problem of vibration with the device was confirmed. It was found that the motor cable had a short circuit. Also the resistance value of the keypad of the handcontrol set was out of range and the locking ring of the drill mounting mechanism was no closing properly. The blade was hence found to not lock into the shaver. The defective drill mounting mechanism, motor cable and the handcontrol set were replaced and the device was repaired, tested and found to be fully functional. User mishandling of the device is the most probable root cause of the physical damage to the locking ring. However, given the information provided, we cannot determine a definitive root cause for the defective keypad of the hand control set and the motor cable. The defective components of the device would have caused the device to not function as intended as reported by the customer. 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 12/29/2015 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.
 
Event Description
It was reported by the affiliate in (b)(6) that during happened during an arthroscopy procedure on an unknown date, it was observed that the micro tornado hp w handcontrol device was not recognized by the pump and that there was a problem of vibration during the procedure. During in-house engineering evaluation, it was determined that the motor cable on the device had a short circuit. There was an unspecified delay in the surgery. Another like device was used to complete the procedure. No additional information could be provided.
 
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 LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key10258793
MDR Text Key200850617
Report Number1221934-2020-01788
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705016938
UDI-Public10886705016938
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
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 Manufacturer06/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
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 Initial

-
-