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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 Corroded (1131)
Patient Problem Not Applicable (3189)
Event Date 07/02/2020
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 device was received and evaluated at the service center. The reported complaint that the hand piece was causing the fms pump connected to it to reset, was confirmed. It was found that the cable of the hand piece was defective and that the hand piece was corroded. The motor cable along with the corroded parts were replaced and the device was repaired, tested and found to be working according to specifications. Fluid ingress into the device is the root cause of the corrosion of the various components of the device. The defective cable and other components would have caused the hand piece to not function as reported by the customer. 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 2/22/2019 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.
 
Event Description
It was reported by sales rep that during a shoulder repair, a fms pump device stopped working when a fms tornado micro handpiece with buttons was connected to it. A new handpiece was used and this second device was also causing pump to reset. A second pump was brought in and the problem persisted. A third shaver handpiece was used to finish the case with a surgical delay of 35 minutes. No patient consequences reported. During in-house engineering evaluation, it was determined that the micro tornado hp w handcontrol device was corroded. 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 Key10339215
MDR Text Key200848916
Report Number1221934-2020-01944
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705016938
UDI-Public10886705016938
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
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 Manufacturer07/20/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
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 Initial

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