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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).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
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.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device was received at the service center and evaluated.There was no allegation of malfunction against the device from the customer, defects were identified during service evaluation.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: the buttons have no function.Functional : cannot control/change speed.The hand control set was replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was 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 to 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 with which this complaint is observed in the field.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.
 
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Brand Name
MICRO TORNADO HP W HANDCONTROL
Type of Device
LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key12108098
MDR Text Key259756917
Report Number1221934-2021-02071
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705016938
UDI-Public10886705016938
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,Followup,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283512
Device Catalogue Number283512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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