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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US AGGRESSIVE 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283419
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (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. Udi: (b)(4).
 
Event Description
It was reported by affiliate via complaint submission the aggressive 4. 0mm 5pk. Again during arthroscopy metal abrasion. Heavy metal abrasion in the ankle joint. No patient consequences. There was a delay of 5 minutes. The device is available for evaluation.
 
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Brand NameAGGRESSIVE 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
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10814463
MDR Text Key216149357
Report Number1221934-2020-03398
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
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 10/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283419
Device Catalogue Number283419
Device Lot NumberM1911020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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