MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Model Number 283913000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

It was reported that (b)(6) 2020, during spinal fusion surgery, the surgeon was using confidence cement with viper fenestrated screws.The pump in the kit lost pressure and came apart.There was a surgical delay of five (5) minutes.There were no fragments generated.Patient status is unknown.The procedure was successfully completed.Concomitant device reported: unknown viper fenestrated screws (part#: unknown, lot#: unknown, quantity: unknown).This report is for one (1) confidence kit, no needles.This is report 1 of 1 for (b)(4).

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.Visual inspection: the confidence kit, no needles (p/n: 283913000, lot #: unk) was returned and received disassembled with no confidence sterilized water at us cq.Upon visual inspection, it was observed that the confidence, pump body assembly component was deeply scratched, the confidence elbow connector body was deformed and unknown foreign material on the device.No other issues were identified with the returned component.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review since the exact manuf.Date of the device was unidentified, reflecting the current revision were reviewed.Confidence final packaging assembly.Confidence pump kit packaging.Confidence pump assembly.Confidence pump body assembly.Complaint confirmed? yes, the received device was fell apart.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the confidence kit, no needles (p/n: 283913000, lot #: unk).There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 KIT, NO NEEDLES
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9817782
• MDR Text Key: 184164277
• Report Number: 1526439-2020-00685
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 03/18/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS