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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 FEMORAL LOCATING DEVICE; KNEE INSTRUMENT : ALIGNMENT DEVICES
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DEPUY ORTHOPAEDICS INC US SP*2 FEMORAL LOCATING DEVICE; KNEE INSTRUMENT : ALIGNMENT DEVICES Back to Search Results
Catalog Number 966110
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/07/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).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 components of femoral locating device for spec2 instrument came apart, all parts retrieved.
 
Additional Manufacturer Narrative
(b)(4).Examination of the returned device revealed breakage.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.
 
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Common Device Name
KNEE INSTRUMENT : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8124123
Report Number1818910-2018-76908
Device Sequence Number19236452
Product Code HWT
UDI-Device Identifier10603295246831
UDI-Public10603295246831
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,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/07/2018
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 Number966110
Device Lot NumberJ1002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Initial Date Received by Manufacturer 11/07/2018
Supplement Date Received by Manufacturer12/04/2018
Initial Report FDA Received Date12/03/2018
Supplement Report FDA Received Date12/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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