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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 REMOVABLE HANDLES PKG 2EA; KNEE INSTRUMENT : HANDLES
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DEPUY ORTHOPAEDICS INC US SP2 REMOVABLE HANDLES PKG 2EA; KNEE INSTRUMENT : HANDLES Back to Search Results
Catalog Number 966147
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/11/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy 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.
 
Event or Problem Description
It was reported that the handles were not connecting and needed to be replaced.
 
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Brand Name
SP2 REMOVABLE HANDLES PKG 2EA
Common Device Name
KNEE INSTRUMENT : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8227521
Report Number1818910-2019-80182
Device Sequence Number19339548
Product Code LXH
UDI-Device Identifier10603295247029
UDI-Public10603295247029
Combination Product (Y/N)N
Initial Reporter StateCO
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) 12/11/2018
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 Number966147
Device Lot NumberD0896
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/11/2018
Initial Report FDA Received Date01/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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