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

Model Number	NL4252-81T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 22sep2021 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 or Problem Description
Per complaint details received: distal tip of kerrion rongeur broke off into patient during procedure (b)(6) 2021 additional information: 1.What was the procedure that was being performed? acdf.2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, with a bayonet forcep.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? fluoroscopy was used throughout case.4.What was the patient¿s outcome? unknown-would need to follow up with glazer (procedure competed as planned).5.Was the procedure completed as planned? yes.6.Can you please send all parts of the instrument for evaluation? yes.7.Do you have the lot number? k19xme.No further information available.
Additional Manufacturer Narrative
Follow up (b)(4).The complaint product was returned, and an evaluation was performed.The root cause of the issue is misuse.Hardness is 46.6 hrc (inside the tolerance 43-48 hrc).The original material certificates were reviewed and found to be conforming.The device was subjected to a microscopic examination.Notches in the cutting edge as well as the general condition of the cutting edge suggest that the punch was blunt.As a result, an increased amount of force was required for cutting.It is unclear what exactly was cut, presumably a punch model that was too weak was selected for the operation, or other objects such as bone wire were cut.There have been no issues identified with the material or manufacturing process.The product would have 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.
Event or Problem Description
Per complaint details received: distal tip of kerrion rongeur broke off into patient during procedure 01oct2021 additional information: 1.What was the procedure that was being performed? acdf.2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, with a bayonet forcep.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? fluroscopy was used throughout case.4.What was the patient¿s outcome? unknown-would need to follow up with glazer (procedure competed as planned).5.Was the procedure completed as planned? yes.6.Can you please send all parts of the instrument for evaluation? yes.7.Do you have the lot number? k19xme.No further information available.

• Brand Name: T-COAT MICRO HDL KERR RONG THIN 8IN 1MM
• Common Device Name: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12569423
• Report Number: 1423507-2021-00044
• Device Sequence Number: 1101085
• Product Code: HAE
• UDI-Device Identifier: 10885403076619
• UDI-Public: (01)10885403076619
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021
• Report Date (Section F): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NL4252-81T
• Device Catalogue Number: NL4252-81T
• Device Lot Number: K19XME
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/04/2021