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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; DISTENSION UNIT, FLUID, ARTHROSCOPIC
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DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 283512
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2019
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.(b)(4).
 
Event Description
It was reported by the sales rep via email that prior to a cadaver lab, the micro tornado handpiece with hand controls appears to have debridement inside the hand piece that will not allow any shavers to attach appropriately or work correctly.There was no patient affected or delay.The device will be returning.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : the complaint device was received at the service center and was not evaluated as it is not for human use.It was reported the micro tornado handpiece with hand controls appears to have debridement inside the hand piece that will not allow any shavers to attach appropriately or work correctly.Per service manual operational and diagnostic, the device could not be evaluated therefore the failure cannot be confirmed.  this device could not be evaluated, and will be placed directly into long term hold because it is a not for human use device.With the given information, we cannot determine the root cause of the reported problem.A manufacturing record evaluation was performed for the finished device [1843m3992r] number, and no non-conformances were identified.  at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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 a manufacturing record evaluation was performed for the finished device [1843m3992r] number, and no non-conformances were identified.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: 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.A manufacturing record evaluation was performed for the finished device [1843m3992r] number, and no non-conformances were identified.
 
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Brand Name
MICRO TORNADO HP W HANDCONTROL
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9526620
MDR Text Key208139204
Report Number1221934-2019-60179
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 company representative,other
Type of Report Initial,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number283512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Date Manufacturer Received01/14/2020
Patient Sequence Number1
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