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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER CS T TRAY; HIP INSTRUMENTS : INSTRUMENT CASES
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER CS T TRAY; HIP INSTRUMENTS : INSTRUMENT CASES Back to Search Results
Model Number 2440-00-504
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/03/2020
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
It was reported that all three inner trays of the pinnacle greater instrument set are stained.
 
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Brand Name
QUICKSET ACE GRATER CS T TRAY
Common Device Name
HIP INSTRUMENTS : INSTRUMENT CASES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10839535
Report Number1818910-2020-24647
Device Sequence Number2838047
Product Code FSM
UDI-Device Identifier10603295123743
UDI-Public10603295123743
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number2440-00-504
Device Catalogue Number244000504
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/03/2020
Supplement Date Received by Manufacturer12/15/2020
Initial Report FDA Received Date11/13/2020
Supplement Report FDA Received Date12/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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