• 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
Catalog Number 283512
Device Problems Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.  (b)(4).
 
Event Description
It was reported by our sales rep that after surgery completed, micro tornado hp w hand control shaver keeps popping out of connector. Connector loose. No patient harm no surgery delay.
 
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The unit was received at the service center and evaluated. As per service manual operational and diagnostic analysis confirms the reported locking knob issue. The cable was damaged. Device disassembled and decontaminated as per the service manual during initial evaluation. The testing of the unit was not completed, due to the need for cable replacement. Unit placed in long term hold. No further investigation beyond what is noted in the service report will be conducted on this complaint. A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. 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. (b)(4).
 
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
MDR Report Key7491831
MDR Text Key107568431
Report Number1221934-2018-50574
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-