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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US AGGRESIVE 5.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK LLC US AGGRESIVE 5.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283719
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 11/03/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be filed as appropriate. Udi: (b)(4)incomplete. The lot number was unknown. 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 austria that during a shoulder repair procedure on (b)(6) 2020, it was observed that there were a lot of metal abrasions during a 10,000 forward with the handpiece device. There was a delay of five minutes in the procedure. Another like device was used to complete the procedure. The fragments were removed easily. There were no adverse patient consequences reported. No additional information was provided.
 
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Brand NameAGGRESIVE 5.0MM 5PK
Type of DeviceARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
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 Key10877260
MDR Text Key217986744
Report Number1221934-2020-03536
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAU
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,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283719
Device Catalogue Number283719
Device Lot NumberM1911049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2019
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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