MAUDE Adverse Event Report: CAREFUSION, INC VITAL COOLEY-BAUMGARTEN WIRE TWIST SERR; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number CH2520

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 06jun2017 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

Customer stated via maude report: the carbide bit for the needle driver came off and was unintentionally retained in the patient.What was the original intended procedure? anterior/posterior cervical fusion.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).The patient was a (b)(6) year old male.No further information available.

• Brand Name: VITAL COOLEY-BAUMGARTEN WIRE TWIST SERR
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• 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
• MDR Report Key: 6634747
• MDR Text Key: 77515552
• Report Number: 1423507-2017-00089
• Device Sequence Number: 1
• Product Code: DWS
• 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: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

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
• Device Operator: Health Professional
• Device Model Number: CH2520
• Device Lot Number: XRBF02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR