MAUDE Adverse Event Report: CAREFUSION, INC T-COAT MICRO HDL KERR RONG THIN 8IN 1MM; KERRISON RONGEURS

Catalog Number NL4252-81T

Device Problem Break (1069)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) on (b)(4) 2018 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 phone conversation: jaw has broken.Additional information received via email on (b)(6) 2018: the date of use was actually 2 different dates.One was on tuesday (b)(6) 2018, and the other on (b)(6) 2018.The kerrisons did break while we were using them in patient¿s necks.There was luckily no harm to the patient or the doctor.Both of the kerrisons that we recently ordered have broken.Lot numbers- c17xme and l17xme.On (b)(6) 2018 additional information: patient information: (age, gender, weight) one male, (b)(6), bmi 34.One female, (b)(6), bmi 30.Was there any patient medical intervention? no.What was the patient¿s medical status after the event? stable.Did any part of the device break/fall into the patient¿s body field? yes, the broken piece of the jaw fell into the neck.If yes how was the object retrieved? with the suction and forceps.Did the patient require an additional medical procedure such as an x-ray? no.How was the event resolved, was the device removed from use and replaced with another? kerrisons were removed from our sets, and now we have two sets down that are incomplete.What type of procedure was being performed? they were both acdf's.Was the procedure completed as planned? yes.Has your facility reported the event to the fda? no.No further information available.

Manufacturer Narrative

The sample was provided and an evaluation was performed.The instrument was manufactured in march of 2017.The root cause is that the punches have been overstressed.Notches in the jaws indicate that the kerrison was used to cut wire.The hardness is 45.4 hrc (inside the tolerance 43-48 hrc).There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: T-COAT MICRO HDL KERR RONG THIN 8IN 1MM
• Type of Device: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 7529583
• MDR Text Key: 109374230
• Report Number: 1423507-2018-00007
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: NL4252-81T
• Device Lot Number: C17XME
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR