• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US 4.0MM ROUND TRDO BURR PLUS 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283479
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Event Description
It was reported by the affiliate in (b)(6) that during an arthroscopy surgery on (b)(6) 2022, it was observed that the terminal of motor on the 4. 0mm round trdo burr plus device seized up. Another like device was used to complete the procedure with an unspecified delay. There were no adverse patient consequences reported. No additional information was provided.
 
Manufacturer 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name4.0MM ROUND TRDO BURR 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 Key13482977
MDR Text Key288029384
Report Number1221934-2022-00431
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283479
Device Catalogue Number283479
Device Lot NumberM1911063
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-