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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 SZ5; KNEE INSTRUMENT : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRIAL SZ5; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Model Number 96-1045
Device Problems Use of Device Problem (1670); Component Missing (2306)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the size 5 box was sent up to (b)(6) with a screw missing.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported damage.The root cause is attributed to improper user technique, and no corrective action is indicated at this time.Depuy synthes 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.
 
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Type of Device
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10309365
MDR Text Key199908568
Report Number1818910-2020-16556
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10603295234739
UDI-Public10603295234739
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number96-1045
Device Catalogue Number961045
Device Lot NumberJ0809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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