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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); Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2021
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 motor did not run smoothly and that the cable was cracked, was confirmed. It was found that the motor did not run as it was corroded. Further, the resistance values of the keypad of the hand control set was out of range and the cable was found to be damaged. The hand piece was found to shut off the pump during operation. The motor, motor cable and the hand control set were replaced and 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. However, given the information provided, we cannot determine a definitive root cause for the defective keypad of the hand control set. Also user mishandling is the most probable root cause of the physical damage to the motor cable. The defective components would have caused the device to shut the pump off during operation. A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformance were 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 customer in (b)(6) that during an arthroscopy procedure on (b)(6) 2021, it was observed that the motor was not running smoothly and the cable was cracked on the handpiece device. During in-house engineering evaluation, it was determined that the motor did not run 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 Key11614697
MDR Text Key244228451
Report Number1221934-2021-01082
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2021
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 Manufacturer03/12/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2018
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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