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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 FEMORAL AUG PLUG PULLER; KNEE INSTRUMENT
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DEPUY IRELAND 9616671 FEMORAL AUG PLUG PULLER; KNEE INSTRUMENT Back to Search Results
Catalog Number 865151
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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 the femoral augment plug puller broke during sterilization process.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary
=
> examination of the submitted device confirmed the reported breakage.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
FEMORAL AUG PLUG PULLER
Common Device Name
KNEE INSTRUMENT
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork IN
EI 
MDR Report Key7064894
Report Number1818910-2017-50322
Device Sequence Number11107244
Product Code LXH
UDI-Device Identifier10603295216711
UDI-Public10603295216711
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 10/31/2017
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 Number865151
Device Lot NumberA0300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2017
Initial Date Received by Manufacturer 10/31/2017
Supplement Date Received by Manufacturer01/09/2018
Initial Report FDA Received Date11/28/2017
Supplement Report FDA Received Date01/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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