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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 SZ1.5; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
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DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL VIEW PLT SZ1.5; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS Back to Search Results
Catalog Number 217865115
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/07/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned device revealed breakage.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 view plate cracked in two pieces.Surgery time was not delayed as we used a size 2.
 
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Brand Name
MBT REV TIBIAL VIEW PLT SZ1.5
Common Device Name
KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7901797
Report Number1818910-2018-70202
Device Sequence Number1394536
Product Code LXH
UDI-Device Identifier10603295096641
UDI-Public10603295096641
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) 08/31/2018
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 Number217865115
Device Lot NumberSO2014925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/31/2018
Initial Report FDA Received Date09/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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