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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNICUT 4.2 RES BLADE 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK LLC US OMNICUT 4.2 RES BLADE 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283345
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Udi: (b)(4). The lot number is unknown at this time.
 
Event Description
It was reported by sales rep via complaint submission tool that during a shoulder repair, metallic deposit was released by the omnicut 4. 2 (used w/ micro handpiece) just after activating the blade (before any contact with the tissue or the bone). Fragments were generated and procedure was completed by cleaning the joint and removing the metal on it with a surgical delay of 5 minutes. Additional information provided by the affiliate reported all fragments were removed from the patient but an x-ray was not done to confirm.
 
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Brand NameOMNICUT 4.2 RES BLADE 5PK
Type of Device ARTHROSCOPIC 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 Key10317812
MDR Text Key200265444
Report Number1221934-2020-01890
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705022472
UDI-Public10886705022472
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
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283345
Device Catalogue Number283345
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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