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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMVAC SINGLE SYRINGE SET BONE CEMENT : CEMENT DELIVERY DEVICES

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DEPUY ORTHOPAEDICS INC US CEMVAC SINGLE SYRINGE SET BONE CEMENT : CEMENT DELIVERY DEVICES Back to Search Results
Catalog Number 831215
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 08/27/2020
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
The revision surgery was performed on (b)(6) 2020 via tha. During the surgery, the surgeon used the syringe to agitate 2 pack cements and to inject the cement to bone-marrow cavity. When the surgeon injected the cement with the syringe, the syringe broke into several fragments with explosion noise. Then, the surgeon could not use the syringe, he plunged the cement which was remained in the syringe to bone-marrow cavity by his hand. The surgeon carefully checked that there was no syringe¿s fragment in the body. The surgery was completed, and it was unknown whether there was any surgical delay. No further information is available.
 
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Brand NameCEMVAC SINGLE SYRINGE SET
Type of DeviceBONE CEMENT : CEMENT DELIVERY DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581-0988
6107428552
MDR Report Key10508835
MDR Text Key206187679
Report Number1818910-2020-19669
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number831215
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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