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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE SHIM SZ7 5MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

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DEPUY IRELAND 9616671 ATTUNE SHIM SZ7 5MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Catalog Number 254500671
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.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 Description
It was reported that the attune size 6 right femur broke into two separate pieces while trailing.It was also reported that the attune shim 5mm size 7 broke into two separate pieces while trailing.No surgical delay.All pieces were retrieved.
 
Manufacturer Narrative
Product complaint #
=
> pc-(b)(4).Investigation summary
=
> examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.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.
 
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Brand Name
ATTUNE SHIM SZ7 5MM
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743725905
MDR Report Key7315805
MDR Text Key101615654
Report Number1818910-2018-54559
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295133537
UDI-Public10603295133537
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/14/2018
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
Device Operator Health Professional
Device Catalogue Number254500671
Device Lot NumberMVMBHP280
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/02/2018
Initial Date FDA Received03/06/2018
Supplement Dates Manufacturer Received03/02/2018
Supplement Dates FDA Received03/06/2018
Date Device Manufactured05/10/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age64 YR
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