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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 Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary
==
> the complaint device was received at the service center and evaluated. It was reported that does not work¿ jammed motor. Per service reports, this complaint can be confirmed. It was found during evaluation that the motor was rusty and sticky. Further, the cable resistance was out of tolerance. Also, some parts of the valve were damaged. The motor, motor cable and damaged valve 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. User mishandling might be the most probable root cause for the damaged valve. However, with the available information, we cannot determine the root cause of the tolerance failure of the cable. The corroded motor and defective cable would have caused the customer to experience the reported problem. 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 05/14/2019 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 the affiliate in (b)(6) that during an unknown surgery on an unknown date, it was observed that the 8022 handpc tornado shaver device had a jammed motor and did not work. During in-house engineering evaluation, it was determined that the motor was sticking as it was corroded. Another like device was used to complete the procedure without delay. There were no adverse patient consequences 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)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key11334069
MDR Text Key245567652
Report Number1221934-2021-00535
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeLO
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 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2021
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 Manufacturer01/26/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2021
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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