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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Catalog Number 283429
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown implant. Part and lot number are unknown. Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 (b)(6) that the 4 mm ultra aggressive blade device on an unknown cutting instrument device jammed and froze at 10000 rpm. There was no procedure nor patient involvement reported. No additional information was provided.
 
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Brand NameULTRA AGGRESSIVE PLUS 4.0MM 5PK
Type of DeviceARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
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 Key11487691
MDR Text Key245511131
Report Number1221934-2021-00859
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283429
Device Lot NumberM2005001
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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