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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US AGGRESSIVE 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 Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). A manufacturing record evaluation was performed for the finished device [m1910006] number, and no non-conformance's were identified. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This is report 2 of 3 for the same event. It was reported by the affiliate in (b)(6) that during an unknown procedure on an unknown date, metallic debris was noted at the beginning of surgery when activating three 4 mm aggressive blade plus. There was a surgical delay of five minutes. All fragments were removed by washing the joint in order to remove the metal. No patient consequences reported. No additional information was provided.
 
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Brand NameAGGRESSIVE 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 LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key10343530
MDR Text Key202229916
Report Number1221934-2020-01957
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705022021
UDI-Public10886705022021
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 07/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283419
Device Catalogue Number283419
Device Lot NumberM1910006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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