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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 283419
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 02/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4).
 
Event Description
It was reported by the affiliate via complaint submission tool that during an unknown procedure 8 of the aggressive 4. 0mm 5pk released metallic debris in the joint. There was no patient consequence, however there was a 5 minutes surgical delay. The procedure was completed washing the joint. No additional information was provided.
 
Manufacturer Narrative
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. Additional narrative: the actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameULTRA AGGRESSIVE PLUS 4.0MM 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 Key9744728
MDR Text Key185077909
Report Number1221934-2020-00656
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 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283419
Device Catalogue Number283429
Device Lot NumberM1906037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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