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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV TC3 BOX TRIAL SZ3; KNEE INSTRUMENT : FEMORAL TRIALS
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DEPUY IRELAND - 9616671 SIG HP REV TC3 BOX TRIAL SZ3; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Catalog Number 201103013
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/16/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: 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 the tc3 femur box feet are broken.Noticed while examining instruments before processing for case.No surgical delay.
 
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Brand Name
SIG HP REV TC3 BOX TRIAL SZ3
Common Device Name
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key7869261
Report Number1818910-2018-69142
Device Sequence Number1337754
Product Code LXH
UDI-Device Identifier10603295081340
UDI-Public10603295081340
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/17/2018
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 Number201103013
Device Lot NumberSO2006618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/17/2018
Initial Report FDA Received Date09/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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