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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIB 2 DEG BROACH 45MM; KNEE INSTRUMENT : BROACHES
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DEPUY ORTHOPAEDICS INC US MBT REV TIB 2 DEG BROACH 45MM; KNEE INSTRUMENT : BROACHES Back to Search Results
Catalog Number 217863113
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/09/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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
O-ring has deteriorated inside trial sleeve and tibial broach.
 
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Brand Name
MBT REV TIB 2 DEG BROACH 45MM
Common Device Name
KNEE INSTRUMENT : BROACHES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8033745
Report Number1818910-2018-74351
Device Sequence Number1465285
Product Code HTQ
UDI-Device Identifier10603295096108
UDI-Public10603295096108
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/24/2018
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 Number217863113
Device Lot NumberA0510
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/24/2018
Initial Report FDA Received Date11/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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