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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
Catalog Number 283512
Device Problems Defective Component (2292); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(6). Investigation summary: the device was received at the service center and evaluated. This reported problem was confirmed. The defect reported by the customer has been verified. The diagnostic assessment had been carried out. As per the service report, the following parts were found to be defective, o-rings, tissue seal set, micro valve screws set, micro motor and jaw kit, lock spring, and micro handcontrol set. However, service was declined by the customer and hence, the system was not restored to specification. The root cause for this failure is undetermined. 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.
 
Event Description
It was reported by the affiliate in (b)(6) that the micro tornado handpiece with hand controls device did not work. During in-house engineering evaluation, it was determined that the following parts on the device were defective, o-rings, tissue seal set, micro valve screws set, micro motor and jaw kit, lock spring, and micro handcontrol set. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown but was noted to have occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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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 LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8197043
MDR Text Key131491840
Report Number1221934-2018-55842
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
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 Manufacturer10/24/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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