MAUDE Adverse Event Report: CAREFUSION, INC VITAL WIRE CUTTER DBL-ACT ANG SIDE CUT; JOINT ARTHROPLASTY DEVICES

Model Number OS3052-001

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

Mat# os3052-001 lot# j22xbf.Verbatim: reported issue: tungsten carbide jaw broke after first use at new surgery center.No excessive pressure on instrument reported and no patient issues.It was used during surgery when the issue occurred.03may2023 additional information: 1.What was the procedure that was being performed? procedure was percutaneous pinning of finger 2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? no part of instrument went into patient 3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? xray was taking to verify 4.What was the patient¿s outcome? patient outcome was good, no issues 5.Was the procedure completed as planned? yes procedure was completed as planned 6.Can you please send all parts of the instrument for evaluation? broken piece was put in sharps box 7.What is the lot number? j22xbf 8.Do you have photos of the reported issue on the instrument? yes i have photos 9.What exactly broke? tungsten carbide jaw broke.No further information available.

Manufacturer Narrative

(b)(4).23apr2023 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 Description

Mat# os3052-001; lot# j22xbf.Verbatim: reported issue: tungsten carbide jaw broke after first use at new surgery center.No excessive pressure on instrument reported and no patient issues.It was used during surgery when the issue occurred.03may2023 additional information: 1.What was the procedure that was being performed? procedure was percutaneous pinning of finger.2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? no part of instrument went into patient.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? xray was taking to verify.4.What was the patient¿s outcome? patient outcome was good, no issues.5.Was the procedure completed as planned? yes procedure was completed as planned.6.Can you please send all parts of the instrument for evaluation? broken piece was put in sharps box.7.What is the lot number? j22xbf.8.Do you have photos of the reported issue on the instrument? yes i have photos.9.What exactly broke? tungsten carbide jaw broke.No further information available.

Manufacturer Narrative

(b)(6) follow up mdr.The sample was provided, and an evaluation was performed.The root cause is overstressing of the instrument.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 WIRE CUTTER DBL-ACT ANG SIDE CUT
• Type of Device: JOINT ARTHROPLASTY DEVICES
• 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: 16955038
• MDR Text Key: 315842262
• Report Number: 1423507-2023-00090
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10885403102943
• UDI-Public: (01)10885403102943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2023,06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OS3052-001
• Device Catalogue Number: OS3052-001
• Device Lot Number: J22XBF
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2023
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention