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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283429
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Subsequent follow-up with the customer, additional information was received. It was reported that the event occurred during knee arthroscopy surgical procedure. It was reported that there were 15 blades involved in the event with two that are missing. Therefore, this is report 1 of 15 for the same event. It was reported that there was a delay of five minutes. It was reported that there were no patient consequences or impact to the user or patient. It was reported that the surgery was completed by changing the blade. It was reported that there were metallic deposits at the start of the surgery. It was reported that an alternative product was readily available. It was reported that there was no surgical intervention planned (e. G. X-rays, additional/change in procedures, prescriptions, otc, revisions). It was reported that the fragments were easily removed without additional intervention by washing the joint. Udi:(b)(4).
 
Event Description
This is report 3 of 15 for the same event. It was reported by the affiliate in (b)(6) that during a knee arthroscopy surgical procedure, it was observed that 15 ultra aggressive plus 4. 0mm 5pk devices had metallic debris/deposits at the start of the surgery. As a result, there was a delay of five minutes as an alternative product was readily available to complete the procedure. It was reported that the surgery was completed by changing the blade. The fragments were easily removed without additional intervention by washing the joint. There were no patient consequences or impact to the user or patient. There was no surgical intervention planned (e. G. X-rays, additional/change in procedures, prescriptions, otc, revisions).
 
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Brand NameULTRA AGGRESSIVE PLUS 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 Key9727897
MDR Text Key207620397
Report Number1221934-2020-00603
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 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283429
Device Catalogue Number283429
Device Lot NumberM1905040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
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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