MAUDE Adverse Event Report: CAREFUSION, INC CHROMA-LINE II SS KERR RONG 8IN 3MM BITE; KERRISON RONGEURS

Catalog Number NL4261-83

Device Problem Break (1069)

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

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4).On (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 attached medwatch report (b)(4): the screw became dislodged from the device, and fell out into the patient.Customer response: what is the date of the event? date of event was on (b)(6) 2020.What was the procedure that was being performed? spinal surgery.How was the screw retrieved? surgeon removed the screw following x-ray visualization of the location.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? x-ray.What was the patient¿s outcome? surgery concluded without further incident, and the patient discharged without post- operative complications.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? yes, all items will be sent back for your evaluation.Do you have the lot number? unsure of lot number.Do you have photos of the reported issue on the instrument? no photos but the device will be returned as requested.No further information available.

Event Description

Per attached medwatch report 0500840000-2020-8007: the screw became dislodged from the device, and fell out into the patient.Customer response: 1.What is the date of the event? date of event was on (b)(6) 2020.2.What was the procedure that was being performed? spinal surgery.3.How was the screw retrieved? surgeon removed the screw following x-ray visualization of the location.4.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? x-ray.5.What was the patient¿s outcome? surgery concluded without further incident, and the patient discharged without post- operative complications.6.Was the procedure completed as planned? yes.7.Can you please send all parts of the instrument for evaluation? yes, all items will be sent back for your evaluation.8.Do you have the lot number? unsure of lot number.9.Do you have photos of the reported issue on the instrument? no photos but the device will be returned as requested.No further information available.

Manufacturer Narrative

Follow up (b)(6).Additional information of lot number xwdt08 (aug 2013) added.The product was returned, and an evaluation was performed on the seven-year-old instrument.The root cause of the reported issue is that the instrument has been reworked by an unauthorized 3rd party repair company.The instrument was disassembled for modification at the front part of the cutting end, which caused the screw lock of the screw to become dislodged from the device during surgery.The device was opened against the instruction for use provided.After the unauthorized repair, the screw was not locked again according to specifications.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.H3 other text : see h10.

• Brand Name: CHROMA-LINE II SS KERR RONG 8IN 3MM BITE
• Type of Device: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10549996
• MDR Text Key: 207539732
• Report Number: 1423507-2020-00039
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NL4261-83
• Device Lot Number: XWDT08
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR