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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
Catalog Number 283512
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the complaint device was received at the service center and evaluated. It was reported that the unit was not working properly. The buttons were not working. Per operational and diagnostic, the reported failure was confirmed. A manufacturing record evaluation was performed for the finished device [1826m3741r] number, and no non-conformances were identified. During evaluation, a short circuit was found in motor's cable, the cable was replaced. Preventive o-rings replacement was performed. The repair and testing of the unit was completed, bringing the unit back to full functionality. The unit passed all functional tests and is fully operational. The possible root cause for the reported failure was thus identified as lack of maintenance and normal wear. At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional. However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field. Udi: (b)(4).
 
Event Description
It was reported by the affiliate via cst that during equipment check before purevue trial it was noticed that two micro tornado hp w handcontrol of fms system are not working properly. Lot1826m3711r - buttons are not working; lot1826m3741r - motor is not working.
 
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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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9428675
MDR Text Key207616878
Report Number1221934-2019-59876
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeLH
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 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
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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