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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 Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary: the complaint device was received at the service center and evaluated. It was reported that the cable of the device was defective. Per service reports, this complaint can be confirmed. It was found during evaluation that the motor was corroded, and cable sheath was cut. Further, keyboard was damaged. The motor, motor cable, keyboard was replaced and upgraded to 1. 25 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. User mishandling might be the most probable root cause for cut in cable sheath and damaged keyboard. The corroded motor, damaged motor cable and damaged keyboard would have caused the customer to experience the reported problem. There are no indications from this complaint investigation that the issue/ failure is manufacturing-related, therefore a manufacturing record evaluation is not required. 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. Device history lot: there are no indications from this complaint investigation that the issue/failure is manufacturing-related, therefore a manufacturing record evaluation is not required.
 
Event Description
It was reported from the affiliate that the micro tornado hp w handcontrol device cable was defective. During an in-house engineering evaluation, it was determined that the device had corrosion/rusting/pitting. It was reported that the device was used in surgery. There was patient involvement. It was not reported if there were any delays in the procedure or whether a like device was available for use. 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 Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11495752
MDR Text Key245502060
Report Number1221934-2021-00860
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 foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2021
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 Manufacturer01/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial
Removal/Correction NumberN/A

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