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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFCSIG INS TRL CURVD 10MMSZ2.5; KNEE TRIAL/INSTRUMENT
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DEPUY IRELAND - 9616671 PFCSIG INS TRL CURVD 10MMSZ2.5; KNEE TRIAL/INSTRUMENT Back to Search Results
Catalog Number 961341
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/30/2017
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 poly trial was broken.No surgical delay.No pieces left in patient.
 
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the device associated with this report were not returned for evaluation.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
PFCSIG INS TRL CURVD 10MMSZ2.5
Common Device Name
KNEE TRIAL/INSTRUMENT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork IN
EI 
MDR Report Key7058169
Report Number1818910-2017-50212
Device Sequence Number1013450
Product Code LXH
UDI-Device Identifier10603295237129
UDI-Public10603295237129
Combination Product (Y/N)N
Initial Reporter StateVA
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) 10/30/2017
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 Number961341
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2017
Supplement Date Received by Manufacturer08/20/2018
Initial Report FDA Received Date11/26/2017
Supplement Report FDA Received Date08/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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