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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary: the complaint device was received at the service center and evaluated. It was reported that the failure was detected during an electrical safety test at the service center. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: the motor is stuck. The defective motor was replaced to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts were identified as the root cause for the device failure during the service evaluation. Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated with manufacturing. 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 to which this complaint is observed in the field.
 
Event Description
It was reported by the affiliate in (b)(6). That during service evaluation, it was determined that the micro tornado hp w handcontrol device failed the electrical safety test. There was no procedure nor patient involvement reported. No additional information was provided.
 
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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 Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key12960585
MDR Text Key281919533
Report Number1221934-2021-03640
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
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 Manufacturer11/24/2021
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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