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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CELCON DARRAH RETRACTOR; EXTREMITY INSTRUMENTS : RETRACTORS
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DEPUY ORTHOPAEDICS INC US CELCON DARRAH RETRACTOR; EXTREMITY INSTRUMENTS : RETRACTORS Back to Search Results
Model Number 2236-31-000
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2020
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
It was reported that while reducing the hip during case, the plastic darrach was leveraged upon and subsequently broke.All pieces were recovered prior to closing.No surgical delay.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
CELCON DARRAH RETRACTOR
Type of Device
EXTREMITY INSTRUMENTS : RETRACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10450689
MDR Text Key204346872
Report Number1818910-2020-18735
Device Sequence Number1
Product Code GAD
UDI-Device Identifier10603295106166
UDI-Public10603295106166
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 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2236-31-000
Device Catalogue Number223631000
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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