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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 Problems Material Frayed (1262); Mechanical Jam (2983); Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary: the device was received at the service center and evaluated. There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation. This complaint can be confirmed. It was found during evaluation that the motor was sticky and rusty. Further, the cable didn't pass the screening test. The motor and motor cable were replaced to resolve the issues. After repair, the device was found to be working according to the specifications. Fluid ingress into the device and contact with the motor is responsible for the rusty motor. Corroded motor has a tendency to stick and not turn. However, with the available information, we cannot determine the root cause of the failure of motor cable screening test. 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 09/03/2015 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 the affiliate in (b)(6) that during service and repair, it was determined that the motor on was jammed and not functioning, and the cable was damaged on the handpiece device. During in-house engineering evaluation, it was determined that the motor was sticking as it was corroded. There was no procedure nor patient involvement reported. No additional information was provided.
 
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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 INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key11447319
MDR Text Key238850908
Report Number1221934-2021-00788
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
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 Manufacturer02/22/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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