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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG CRVD+ INS TRL 5 10MM; KNEE INSTRUMENT : TIBIAL TRIALS
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DEPUY ORTHOPAEDICS INC US SIG CRVD+ INS TRL 5 10MM; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Catalog Number 972371
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).Investigation summary : examination of the returned device confirmed the reported breakage.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.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 curved insert trial (5x10mm) was broken around the rim.The piece that broke off was retrieved.
 
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Brand Name
SIG CRVD+ INS TRL 5 10MM
Common Device Name
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8257026
Report Number1818910-2019-81284
Device Sequence Number2307563
Product Code LXH
UDI-Device Identifier10603295251224
UDI-Public10603295251224
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/26/2018
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 Number972371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/26/2018
Initial Report FDA Received Date01/17/2019
Patient Sequence Number1
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