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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 Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). The device was received and evaluated at the service center. The reported complaint that the set rotation speed of the hand piece and the actual rotation speed do not match was confirmed. It was found that the resistance values of the keypad were out of range and that the keypad was not responding properly. Further, the motor was stuck and the protective earth resistance of the motor cable was out of range. The motor, the motor cable and the hand control set were replaced and the device was repaired, tested and found to be fully functional. Fluid ingress into the device is one possible root cause of the damage to the motor. However, given the information provided, we cannot discern a definitive root cause of the other defective parts. The defective components of the device would have caused the device to not function as intended as reported 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.
 
Event Description
It was reported by the affiliate in (b)(6) that the set rotation speed and the actual rotation speed did not match on the micro tornado hp w handcontrol device. During in-house engineering evaluation, it was determined that the resistance values of the keypad were out of range and that the keypad was not responding properly. Furthermore, the motor was stuck and the protective earth resistance of the motor cable was out of range. There was no procedure involved reported. There were no adverse patient consequences 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 (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 Key11081354
MDR Text Key224404972
Report Number1221934-2020-04015
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,foreig
Type of Report Initial
Report Date 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2020
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 Manufacturer11/06/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
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 Initial
Removal/Correction NumberN/A

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