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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA INSET PATELLA CLAMP HEAD; KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS
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DEPUY ORTHOPAEDICS INC US SIGMA INSET PATELLA CLAMP HEAD; KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS Back to Search Results
Catalog Number 966683
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/14/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the device associated with this report was not returned for evaluation.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 patella clamp would not properly connect to the patella clamp attachment.Attachment would fall when tilted into a downward angle.
 
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Brand Name
SIGMA INSET PATELLA CLAMP HEAD
Common Device Name
KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8230825
Report Number1818910-2019-80270
Device Sequence Number13690543
Product Code HXD
UDI-Device Identifier10603295249610
UDI-Public10603295249610
Combination Product (Y/N)N
Initial Reporter StateOH
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) 12/18/2018
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 Number966683
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/18/2018
Initial Report FDA Received Date01/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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