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

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.

• Brand Name: T-COAT MICRO HDL KERR RONG 8IN 4MM BITE
• Type of Device: RONGEUR, 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 Key: 6731228
• MDR Text Key: 203276716
• Report Number: 1423507-2017-00098
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• 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 Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NL4251-84T
• Device Lot Number: XMEV11
• 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 Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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