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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 Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/15/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: the device was received and evaluated at the service center. The reported complaint that the suction lever was stuck and that the feature would not turn on, was confirmed. It was further found that the cable, motor and the button of the device were defective. The handpiece was also found to be physically damaged. The defective parts were replaced and the device was tested and found to be working according to specifications. The physical damage to the handpiece is most likely a result of user mishandling of the device, possibly during transportation or storage. The damaged components of the handpiece would have caused it to not function as intended by the customer. A manufacturing record evaluation was performed for the finished device (serial number: (b)(4), and no non-conformances were identified. 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 the sales rep via phone that during a shoulder repair procedure the customer's micro tornado handpiece with hand controls suction lever was stuck and that feature would not turn on. The case was completed with another like-device with no patient harm or delay. The device is being returned.
 
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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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9789128
MDR Text Key205929090
Report Number1221934-2020-00755
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 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2020
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 Manufacturer02/10/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
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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