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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRL SZ5 11MM; KNEE INSTRUMENT : TIBIAL TRIALS
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DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRL SZ5 11MM; KNEE INSTRUMENT : TIBIAL TRIALS Back to Search Results
Model Number 2024-11-511
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2020
Event Type  malfunction  
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 Description
At the receipt, the device was broken into 2 parts.The test insert is complete, but it is separate from the handle.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned for examination.The investigation could not draw any conclusions about the reported event without the device to examine.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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
SIGMA HP UNI TIB TRL SZ5 11MM
Type of Device
KNEE INSTRUMENT : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10860016
MDR Text Key216938215
Report Number1818910-2020-24902
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295082910
UDI-Public10603295082910
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2024-11-511
Device Catalogue Number202411511
Was Device Available for Evaluation? No
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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