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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); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary : the complaint device was received at the service center and evaluated. It was reported that does not work on, cracked cable. Per service reports, this complaint can be confirmed. It was found during evaluation that the motor was corroded and does not run. Further, the button was not functioning, and cable was damaged. Also, found that 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. Additionally, when the resistance values of the keypad 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. A manufacturing record evaluation was performed for the finished device serial number ((b)(4)), and no non-conformance was identified. 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 sales rep in (b)(6) that during an unknown surgery on an unknown date, it was observed that the micro tornado hp w handcontrol device did not work and had a cracked cable. During in-house engineering evaluation, it was determined that the motor was corroded and did not run. 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 Key11505501
MDR Text Key245377577
Report Number1221934-2021-00866
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2021
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 Manufacturer03/02/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2016
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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