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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 Crack (1135); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 device doesn't turn due to a jammed motor, and that the cable was cracked, was confirmed. It was found that the motor did not run constantly as it was corroded. Further, the resistance values of the keypad of the hand control set and the protective earth resistance of the motor cable were out of range, and the buttons of the keypad were not functioning, the motor was sticking and also the cable was damaged. The motor, motor cable and the hand control set were replaced, the device was modified as per the specifications of the manufacturer, 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. The corroded motor has a tendency to stick and not turn, hence is responsible for the issue reported by the customer. The damaged cable is most likely a result of user mishandling of the device. However, given the information provided, we cannot determine a definitive root cause for 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 01-jun-2018 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. However, depuy synthes 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 preoperatively to an arthroscopy procedure on an unknown date, it was observed that the micro tornado hp w handcontrol device had a jammed motor, cracked cable, and would not turn. During in-house engineering evaluation, it was determined that the motor did not run constantly as it was corroded. Another like device was used to complete the procedure without delay. 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 Key11366644
MDR Text Key233591347
Report Number1221934-2021-00616
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 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
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 Manufacturer02/10/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
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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