MAUDE Adverse Event Report: CAREFUSION, INC TA KERRISON RONG. 8'', 2MM BITE, 40 UP; KERRISON RONGEURS

Catalog Number NL4291-82T

Device Problems Defective Device (2588); 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.The 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.The 19jul2018 additional information: the case was delayed 5-10 minutes.No further information available.

Manufacturer Narrative

Follow up 477550 the samples were provided and an evaluation was performed.The root cause is overstressing of the instrument.The hardness is inside the tolerance of 43-48 hrc.The unlocking mechanisms were not operated properly and were damaged / bent with a great expenditure, or the punches have been overstressed.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.The product has been manufactured and tested according to the specifications.

Event Description

Via email: instrument was defective.18jul2018 additional information: 1.Was the product received in this condition? no 2.If not, what was the product being used for when it was observed that the instrument was defective? being used in surgery 3.Please confirm whether there was any patient impact.Delay in case, but no injury to the patient.4.What exactly is wrong with the instrument? bending in the shaft 19jul2018 additional information: the case was delayed 5-10 minutes.No further information available.

• Brand Name: TA KERRISON RONG. 8'', 2MM BITE, 40 UP
• Type of Device: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 7746866
• MDR Text Key: 116402663
• Report Number: 1423507-2018-00016
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• 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: No Information
• Device Catalogue Number: NL4291-82T
• Device Lot Number: B17XME
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other