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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
(b)(4). Investigation summary: the device was received and evaluated at the service center. The customer requested a repair, defects were found with the device during evaluation, therefore we can confirm this complaint. It was found that the motor sticks and was rusty. Further, the motor cable did not pass the cable screening test. The motor and the 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 would have caused the damage to the motor cable, causing it to fail the screening test. The corroded motor has a tendency to stick and not turn. The defective components of the device would have caused the device to not function as intended 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 05/30/2017 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 affiliate via email the 8022 handpc tornado shaver. Customer request for the device repair. No further information was provided. The device is available to be returned for evaluation. Additional information provided by the affiliate reported the event occurred pre-operaively and a patient was not involved.
 
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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 Key10666177
MDR Text Key210987796
Report Number1221934-2020-02955
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
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 Number288022
Device Catalogue Number288022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
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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