MAUDE Adverse Event Report: CAREFUSION, INC T-COAT MICRO HDL KERR RONG THIN 8IN 2MM; KERRISON RONGEURS

Catalog Number NL4258-82T

Device Problem Break (1069)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4).(b)(6) 2020 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

Per email: event description per attached email states: a tiny piece that broke off during a procedure.30sep2020 additional information: what was the procedure that was being performed? the procedure being performed was a laminectomy.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? the tip of the roguer broke off and fell into the incision area and went in between the lamina and the dura.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? there was x-ray being done throughout the case.What was the patient¿s outcome? the patient¿s outcome was fine.Was the procedure completed as planned? yes, the procedure was completed as planned.Can you please send all parts of the instrument for evaluation? yes, we can send the parts.Do you have the lot number? na.No further information available.

Event Description

Event description per attached email states: a tiny piece that broke off during a procedure.30sep2020 additional information: what was the procedure that was being performed? the procedure being performed was a laminectomy.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? the tip of the roguer broke off and fell into the incision area and went in between the lamina and the dura.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? there was x-ray being done throughout the case.What was the patient¿s outcome? the patient¿s outcome was fine.Was the procedure completed as planned? yes, the procedure was completed as planned.Can you please send all parts of the instrument for evaluation? yes, we can send the parts.Do you have the lot number? na.No further information available.

Manufacturer Narrative

Follow up 1857615.The product was returned, and an evaluation was performed on the over ten-year-old instrument.The root cause of the reported issue is that the instrument has been reworked by an unauthorized 3rd party repair.Hardness is 46.9 hrc, which is inside the tolerance 43-48 hrc.The device was subjected to a microscopic examination.Marks on the slider, the tip and the screws indicate improper repair by an unauthorized repair service.The cutting edge was blunt due to the poor repair, so more force was needed to cut.The foot plate was grinded by the repair service, reducing material stability and thus increasing the risk of breakage.The increased effort required due to the blunt cutting edge and the reduction in footplate thickness led to breakage of the tip.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.See h10.

• Brand Name: T-COAT MICRO HDL KERR RONG THIN 8IN 2MM
• Type of Device: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10609265
• MDR Text Key: 221547261
• Report Number: 1423507-2020-00043
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL4258-82T
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention