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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 Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: the device was received and evaluated at the service center. The reported complaint that the device doesn't hold burrs was unable to be confirmed. However, it was found that the values of the keypad were out of range and the keypad was not responding properly. The defective hand control set was replaced and the device was cleaned, repaired, tested and found to be fully functional. Since the reported condition is not confirmed, the root cause for the reported failure cannot be determined. Also, given the information provided, we cannot discern a definitive root cause of 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 08/18/2020 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. 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. Udi: (b)(4).
 
Event Description
It was reported by affiliate via phone that during an unknown procedure a fms tornado micro handpiece with buttons did not hold burrs. Procedure was completed with a replacement device. No patient consequences or surgical delay reported.
 
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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
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10706545
MDR Text Key212366605
Report Number1221934-2020-03087
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
Reporter Occupation
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
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 Manufacturer10/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
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

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