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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION MODULAR STOP; ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES
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DEPUY IRELAND - 9616671 ATTUNE REVISION MODULAR STOP; ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES Back to Search Results
Catalog Number 254600500
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/17/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 7 attune revision modular stop pieces do not work with the tibial stem reamer, they do not slide down to lock in.There was a manufacturing problem and it was never in a surgery.
 
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Brand Name
ATTUNE REVISION MODULAR STOP
Common Device Name
ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork, munster
EI 
MDR Report Key7800613
Report Number1818910-2018-67197
Device Sequence Number1536483
Product Code LXH
UDI-Device Identifier10603295478607
UDI-Public10603295478607
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/30/2018
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 Catalogue Number254600500
Device Lot NumberSO2028208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/30/2018
Initial Report FDA Received Date08/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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