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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 Problems Material Frayed (1262); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
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 an arthroscopy procedure on (b)(6) 2021, it was observed that the button on the micro tornado hp w hand control device fell out.It was further reported that the device had a cracked cable.Another like device was used to complete the procedure.There were no adverse patient consequences 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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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.It was reported that cracked cable, dropped out button.Per service reports, this complaint can be confirmed.It was found during evaluation that the motor was corroded and does not running constantly.Further, the buttons and cable were damaged, the protective earth resistance and the values of the keypad were out of range.The motor, motor cable and hand control set were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Fluid ingress into the device and contact with the motor is responsible for the rusty motor.Corroded motor has a tendency to stick and not turn.Further, user mishandling might be the most probable root cause for the damaged cable and button.Additionally, when the resistance values of the keypad and cable are out of range, the keypad of the device may not respond, therefore is a potential root cause which could impact the functionality of the device causing it not to function as intended.However, we cannot determine what caused the out of tolerance failure.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 04/10/2019 and passed all functional testing before being returned to the customer.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.
 
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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 Key11344995
MDR Text Key232551324
Report Number1221934-2021-00584
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
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 Manufacturer02/10/2021
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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