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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 Corroded (1131)
Patient Problem Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: (b)(6).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device does not work was confirmed, it was found that the motor was corroded and doesn't run.Further, the tissue seal kit was damaged and the resistance values of the keypad of the hand control set and the protective earth resistance of the motor cable were out of range.The motor, 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 system and contact with the motor is responsible for the corrosion of the motor and would have caused the damage to the motor cable.The corroded motor has a tendency to stick and not turn, hence is responsible for the issue reported by the customer.However, given the information provided, we cannot determine a definitive root cause for the defective keypad of the hand control set and the damaged tissue seal kit.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 07/15/2019 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.Udi:(b)(4).
 
Event Description
It was reported by affiliate via phone that a fms tornado micro handpiece with buttons does not work anymore.No surgical delay or patient consequence reported.Additional information provided by the affiliate reported the event occurred intra-op during a shoulder arthroscopy.It was also reported a 5 minute delay occurred and the procedure was successfully completed with a spare device.
 
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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
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10411034
MDR Text Key203129968
Report Number1221934-2020-02104
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705016938
UDI-Public10886705016938
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer07/17/2020
Initial Date Manufacturer Received 08/13/2020
Initial Date FDA Received08/14/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
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