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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRIAL SZ4; KNEE INSTRUMENT : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRIAL SZ4; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Model Number 96-1044
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/06/2020
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 set screw is stripped.No surgical delay.
 
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: examination of the returned device confirmed the stripped condition.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.
 
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Common Device Name
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10308658
Report Number1818910-2020-16530
Device Sequence Number16998380
Product Code LXH
UDI-Device Identifier10603295234722
UDI-Public10603295234722
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/06/2020
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 Model Number96-1044
Device Catalogue Number961044
Device Lot NumberJ0904
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2020
Initial Date Received by Manufacturer 07/06/2020
Supplement Date Received by Manufacturer07/28/2020
Initial Report FDA Received Date07/22/2020
Supplement Report FDA Received Date07/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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