MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE HALF DOSE KIT (5CC); POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number	283905000
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, during a kyphoplasty case with a confidence cement kit, the cement did not connect to the port that holds the cement after mixing.The cement kit mixing cement was extremely hard to the point, making it impossible to transfer.Three (3) more cement kits were used and unspecified issues of not being able to connect occurred again.The procedure and patient status is unknown.Surgical delay is unknown.Concomitant devices reported: confidence half dose kit (5cc) (part# unknown, lot# unknown, quantity# 4).This is report 1 of 1 for (b)(4).
Event or Problem Description
Concomitant devices reported: confidence half dose kit (5cc) (part# 283905000, lot# unknown, quantity# 3).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE HALF DOSE KIT (5CC)
• Common Device Name: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9805663
• Report Number: 1526439-2020-00664
• Device Sequence Number: 3002654
• Product Code: NDN
• UDI-Device Identifier: 10705034209555
• UDI-Public: (01)10705034209555
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 283905000
• Device Catalogue Number: 283905000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONFIDENCE HALF DOSE KIT (5CC) QTY 3; QUANTITY 4