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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION REAMER 14MM; KNEE INSTRUMENT : REAMERS
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DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION REAMER 14MM; KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863174
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: functional testing of the returned device confirmed the reported event.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 reamers was stripped.
 
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Brand Name
MBT REVISION REAMER 14MM
Common Device Name
KNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7666049
Report Number1818910-2018-63873
Device Sequence Number14110702
Product Code HTO
UDI-Device Identifier10603295096313
UDI-Public10603295096313
Combination Product (Y/N)N
Initial Reporter StateNH
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) 06/12/2018
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 Number217863174
Device Lot NumberA0804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/12/2018
Initial Report FDA Received Date07/06/2018
Patient Sequence Number1
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