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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL VIEW PLT SZ4; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
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DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL VIEW PLT SZ4; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS Back to Search Results
Catalog Number 217865140
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2019
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.Examination of the submitted mbt rev tibial view plt sz4 confirmed it had broken into two pieces.All pieces were returned.Root cause attributed to the device being worn from normal use and servicing.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.
 
Event or Problem Description
During inspection, it was noticed that product was damaged.
 
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Brand Name
MBT REV TIBIAL VIEW PLT SZ4
Common Device Name
KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8670415
Report Number1818910-2019-95274
Device Sequence Number11295333
Product Code LXH
UDI-Device Identifier10603295096689
UDI-Public10603295096689
Combination Product (Y/N)N
Initial Reporter CountryPO
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/16/2019
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 Number217865140
Device Lot NumberSO2035211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/17/2019
Initial Report FDA Received Date06/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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