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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 No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: the device was received and evaluated at the service center. The reported complaint that the device doesn't turn due to a jammed motor was confirmed. It was found that the motor was corroded and runs not constantly. Further, the cable and tissue seal were found to be damaged and the resistance values of the keypad were out of range. The motor, motor cable and the hand control set were replaced and the device was repaired, tested and found to be fully functional. Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor. The corroded motor has a tendency to stick and not turn, hence is responsible for the issue reported by the customer. Also the damage to the tissue seal and motor cable may have been a result of user mishandling of the device, however, given the information provided, we cannot determine a definitive root cause for the same, along with that of the hand control set. A manufacturing record evaluation was performed for the finished device (serial number : 1851m4024r), and no non-conformances were identified. 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, the micro tornado hp w handcontrol. Doesn¿t turn jammed motor. The arthroscopy procedure was completed with a replacement. No delay. No patient consequences. The device is available to be returned for evaluation.
 
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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 Key10662836
MDR Text Key210986049
Report Number1221934-2020-02953
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeEZ
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 09/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2020
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 Manufacturer09/22/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
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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