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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 Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the cable of the device was stripped was confirmed.It was found that the cable sheath was cut, the keyboard resistance value was out of tolerance limits.And that the motor was corroded.The motor, the motor cable and the hand control set were replaced and the device was repaired, tested and found to be fully functional.The physical damage to the cable is a result of user mishandling of the device by the user.Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor.However, given the information provided, we cannot discern a definitive root cause of the defective keypad of the hand control set.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 08/05/2019 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.
 
Event Description
It was reported by the customer in (b)(6) that during an unknown procedure on (b)(6) 2020, it was observed that the cable on the micro tornado hp w handcontrol the device was stripped.During in-house engineering evaluation, it was determined that the motor on the device was corroded.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
 
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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 LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key11047085
MDR Text Key222787579
Report Number1221934-2020-03984
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/08/2020
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 Manufacturer11/23/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/21/2020
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
Patient Sequence Number1
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