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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 10/30/2020
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). Investigation summary:the complaint device was received at the service center and evaluated. It was reported that device does not work. The cable is stripped. Per service reports, this complaint can be confirmed. It was found during evaluation that the motor was corroded. Further, keyboard was damaged and cable sheath was cut. The motor, motor cable and keyboard 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. The damage to the keyboard and cut in cable sheath is most likely due to user mishandling of the device. The corroded motor, damaged keyboard and cut in cable sheath 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.
 
Event Description
It was reported by the customer in (b)(4) that during an unknown procedure on 10/30/2020, it was observed that the cable on the micro tornado hp w handcontrol was stripped, and that the device did not work. 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 Key11245911
MDR Text Key229293826
Report Number1221934-2021-00285
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
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 01/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2021
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 Manufacturer11/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
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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