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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: udi: (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the affiliate in belgium that during service evaluation, it was determined that the 8022 handpc tornado shaver device failed the electrical safety test. 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 Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key12987429
MDR Text Key285169838
Report Number1221934-2021-03714
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 Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
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 Manufacturer12/01/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/06/2022
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 Unkown

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