• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC T-COAT MICRO HDL KERR RONG 8IN 4MM BITE RONGEUR, MANUAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION, INC T-COAT MICRO HDL KERR RONG 8IN 4MM BITE RONGEUR, MANUAL Back to Search Results
Model Number NL4251-84T
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/06/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The samples were provided and an evaluation was performed. The instruments were manufactured in november of 2014. The instruments have been reworked by an unauthorized 3rd party repair company, and afterward the screws were not properly locked. One instrument was very deformed, indicating improper use. Hardness was tested at 46. 5 hrc and 46. 8 hrc which is within tolerance of 43-48 hrc. There have been no issues identified with the material or manufacturing process. A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue. On initial mdr, adverse event and serious injury were inadvertently left off the submission.
 
Manufacturer Narrative
(b)(4) on 07jul2017 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Sales rep stated via email: screws fell out during surgery. What was the procedure that was being performed? posterior lumbar fusion/fixation for the 4 mm kerrison and an acdf for the 2 mm kerrison. Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, the upper screw on the 4 mm kerrison, it was retrieved and the larger lower screw on the 2 mm kerrison and it was retrieved as well. Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no, it was visibly removed and the screw was intact not broken. What was the patient¿s outcome? no harm to the pt. Since the screw was removed. Was the procedure completed as planned? yes, the procedure was completed. Can you please send all parts of the instrument for evaluation? the parts were given to sales rep. No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameT-COAT MICRO HDL KERR RONG 8IN 4MM BITE
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6731228
MDR Text Key203276716
Report Number1423507-2017-00098
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL4251-84T
Device Lot NumberXMEV11
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2014
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/21/2017 Patient Sequence Number: 1
-
-