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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 8022 HANDPC TORNADO SHAVER LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

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DEPUY MITEK LLC US 8022 HANDPC TORNADO SHAVER LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM Back to Search Results
Model Number 288022
Device Problem Corroded (1131)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (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 sticks and is rusty. Further, the cable resistance was out of tolerance. The motor and motor cable 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 and could have caused the damage to the motor cable. The corroded motor has a tendency to stick and not turn, hence is responsible for the issue 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 06/08/2020 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. Udi: (b)(4).
 
Event Description
It was reported by the affiliate via service request that the 8022 handpc tornado shaver doesn¿t turn and has a jammed motor. The procedure was completed with a replacement device and no surgical delay or impact on the patient was reported.
 
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Brand Name8022 HANDPC TORNADO SHAVER
Type of DeviceLINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS INT MITEK
chemin blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10706272
MDR Text Key212184225
Report Number1221934-2020-03085
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 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number288022
Device Catalogue Number288022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
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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