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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 SZ6; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
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DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL VIEW PLT SZ6; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS Back to Search Results
Catalog Number 217865160
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/21/2018
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 instrument cracked over time and finally broke.
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).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
MBT REV TIBIAL VIEW PLT SZ6
Common Device Name
KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7439479
Report Number1818910-2018-57596
Device Sequence Number1160655
Product Code LXH
UDI-Device Identifier10603295096702
UDI-Public10603295096702
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 03/21/2018
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 Number217865160
Device Lot NumberA1009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2018
Initial Date Received by Manufacturer 03/21/2018
Supplement Date Received by Manufacturer04/18/2018
Initial Report FDA Received Date04/18/2018
Supplement Report FDA Received Date04/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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