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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US 4.0MM MULTIBLADE PLUS 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283439
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
The device serial or lot number was unknown; therefore, udi: (b)(4). The device serial or lot number is 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 (b)(6) that during an unknown procedure on (b)(6) 2020, it was observed that the 4. 0mm multiblade plus device was clogged. It was reported that there was a less than one minute delay in the procedure. It was not reported whether a like device was available for use. There were no adverse patient consequences reported. No additional information was provided.
 
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Brand Name4.0MM MULTIBLADE PLUS 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 Key10995328
MDR Text Key221283916
Report Number1221934-2020-03847
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283439
Device Catalogue Number283439
Device Lot NumberM2003061
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 Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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