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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SP2 FEM LUG DRILL W/HUD END; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910 SP2 FEM LUG DRILL W/HUD END; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 966202
Medical Device Problem Codes Break (1069); Dull, Blunt (2407)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/17/2017
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 the drill is rounded off and has notches.
 
Additional Manufacturer Narrative
Examination of the returned device confirmed the reported damage.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.
 
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Brand Name
SP2 FEM LUG DRILL W/HUD END
Common Device Name
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7034221
Report Number1818910-2017-29011
Device Sequence Number685457
Product Code HWE
UDI-Device Identifier10603295247272
UDI-Public10603295247272
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/17/2017
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 Number966202
Device Lot NumberMX0107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2017
Initial Date Received by Manufacturer 10/17/2017
Supplement Date Received by Manufacturer11/17/2017
Initial Report FDA Received Date11/15/2017
Supplement Report FDA Received Date11/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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