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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP DIS FEM BLK; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP DIS FEM BLK; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 950501236
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 drill broke off inside the sigma distal femoral cutting block.
 
Additional Manufacturer Narrative
Examination of the returned device was unable to confirm 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.
 
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Brand Name
SIGMA HP DIS FEM BLK
Common Device Name
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key6739899
Report Number1818910-2017-21689
Device Sequence Number772137
Product Code NJL
UDI-Device Identifier10603295225416
UDI-Public10603295225416
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
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,Followup
Report Date (Section B) 06/27/2017
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 Number950501236
Device Lot NumberJ1108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2017
Initial Date Received by Manufacturer 06/27/2017
Supplement Date Received by Manufacturer11/30/2017
Initial Report FDA Received Date07/25/2017
Supplement Report FDA Received Date11/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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