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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4).
 
Event Description
The cable is broken. No further information available.
 
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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 Key10845123
MDR Text Key216417602
Report Number1221934-2020-03495
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2020
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 Manufacturer11/06/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
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
Removal/Correction NumberN/A

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