MAUDE Adverse Event Report: CAREFUSION, INC TA KERRISON RONG. 8", 4MM BITE, 40 UP KERRISON RONGEURS

Catalog Number NL4291-84T

Device Problems Defective Component (2292); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). On 09jul2018 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

Via email: instrument was defective. On 18jul2018 additional information: was the product received in this condition? no. If not, what was the product being used for when it was observed that the instrument was defective? being used in surgery. Please confirm whether there was any patient impact. Delay in case, but no injury to the patient. What exactly is wrong with the instrument? bending in the shaft. On 19jul2018 additional information: the case was delayed 5-10 minutes. No further information available.

• Brand Name: TA KERRISON RONG. 8", 4MM BITE, 40 UP
• Type of Device: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 7746660
• MDR Text Key: 116537748
• Report Number: 1423507-2018-00015
• Device Sequence Number: 0
• Product Code: HAE
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: NL4291-84T
• Device Lot Number: D17XME
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/03/2018 Patient Sequence Number: 1