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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PINNACLE GRATER HEAD CASE; PROJECT NEPTUNE : INSTRUMENT CASES
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DEPUY IRELAND - 9616671 PINNACLE GRATER HEAD CASE; PROJECT NEPTUNE : INSTRUMENT CASES Back to Search Results
Model Number 2220-00-100
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation summary: depuy international reports air bubbles in the foil of the tray.The examination of the returned tray confirmed the complaint.
 
Event Description
It was reported that there are air bubbles in the foil of the tray.
 
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Brand Name
PINNACLE GRATER HEAD CASE
Type of Device
PROJECT NEPTUNE : INSTRUMENT CASES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10159761
MDR Text Key195387112
Report Number1818910-2020-13922
Device Sequence Number1
Product Code FSM
UDI-Device Identifier10603295424178
UDI-Public10603295424178
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2220-00-100
Device Catalogue Number222000100
Device Lot NumberPV0175268
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2019
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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