MAUDE Adverse Event Report: CAREFUSION, INC VITAL ADVANCED WIRE CUTTER 7IN RIGHT; CUTTER, WIRE

Catalog Number	OS3032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr # (b)(4).18aug2023 writer sent the customer an email acknowledging receipt of the complaint 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
"black insert piece cracked in half during procedure".No patient impact.22aug2023 additional information: what is the lot number for the defective cutter? k22xbf.How many occurrences of the defective cutter(s)? one.What was the procedure that was being performed? cabg.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, one broken piece retrieved by surgical team.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.What was the patient¿s outcome? no harm.Was the procedure completed as planned? yes.No further information is not available.
Event or Problem Description
"black insert piece cracked in half during procedure".No patient impact.22aug2023 additional information: what is the lot number for the defective cutter? k22xbf.How many occurrences of the defective cutter(s)? one.What was the procedure that was being performed? cabg.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, one broken piece retrieved by surgical team.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.What was the patient¿s outcome? no harm.Was the procedure completed as planned? yes.No further information is not available.
Additional Manufacturer Narrative
Pr # (b)(4) follow up: the sample was provided, and an evaluation was performed.The root cause is misuse of the instrument.The reason for the crack in the rubber guard of the wire cutter is that a kirschner wire was cut twice in succession with minimal clearance.During the second cut, the sharp end of the wire was pressed into the splash guard, which then naturally snapped.The function of the rubber guard is no longer guaranteed by the crack.Use of a device for a task other than what it is intended for will usually result in a damaged or broken device.Prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage.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.

• Brand Name: VITAL ADVANCED WIRE CUTTER 7IN RIGHT
• Common Device Name: CUTTER, WIRE
• 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: 17625146
• Report Number: 1423507-2023-00098
• Device Sequence Number: 15274627
• Product Code: HXZ
• UDI-Device Identifier: 10885403102769
• UDI-Public: (01)10885403102769
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023
• Report Date (Section F): 08/25/2023

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 Catalogue Number: OS3032
• Device Lot Number: K22XBF
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: Required Intervention
• Patient Sex: Unknown