MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONFIDENCE KIT SPINAL CEMENT SYSTEM - NO NEEDLE; CEMENT, BONE, VERTEBROPLASTY

Model Number 283913000

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.Awaiting sample: a follow up report will be filed upon completion of the investigation.Device not yet returned for evaluation.

Event Description

After the technician placed the pmma and liquid into the mixing bowl, the wiper was placed in the correct fashion.The mix handle was placed,however, the two pieces together began to crack and the mixer seemed to mix ineffectively.Mix was less than 45 seconds.Then tried to extrude the cement out of mixing bowl into reservoir.Cement was very thick and would not extrude very well.The hydraulic pump also had liquid passing through basket.Product was abandoned.Patient was not affected.

Manufacturer Narrative

The confidence cement kit was returned for evaluation.Visual inspection revealed that the pump was one third empty with some water released from the pressure relief valve.The cement reservoir was filled to approximately the 7mm graduation.A portion of additional cement remains in the mixer.The cement appears to be homogeneous.No damage was noted on the mixer.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be definitively determined using the returned sample and information provided.It is possible that the difficulties experienced while mixing the cement may have led to the cement beginning to set prior to use ultimately causing the pressure relief valve to trigger.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends have been observed, this complaint file will be closed with no further action required.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 SPINAL CEMENT SYSTEM - NO NEEDLE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6757907
• MDR Text Key: 81608041
• Report Number: 1526439-2017-10625
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 103636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR