MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE SPINAL CEMENT SYSTEM; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283907000

Device Problems No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: unknown.A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Vertebroplasty.Water pushed into the cement chamber in front of the cement.Follow up received on 18-apr-2016: all steps of mixing were followed.When the hydraulic pump was pressurized the cement didn't advance in the cement chamber.Water filled the cement chamber in front of the cement (the distal portion of the cement chamber).

Manufacturer Narrative

Additional narrative: one (1) confidence kit 7cc [product code: 2839-07-000] was returned to the complaints handling unit (chu) for evaluation.Visually nothing could be found wrong with the confidence pump.The pump was then filled with water and pressurized until the safety valve engaged and there was no water leakage from the pump, the cement reservoir, or any of the connectors.No difficulties engaging and disengaging between the connections of the rectus connector and the injector piston connection was observed.Pump was then tested with a pressure gage to ensure the output of the correct pressure.Pump pressure maxed out at 182 bar before the safety valve engaged.The pump pressure results are within the specification according to the manufacturing process specification.There have been no pump failures identified in this complaint file.It should be noted that once the relieve valve is activated it is normal for sterile water to leak from the distal end of the devices.As such, the confidence pump is functioning as intended with no affect on product form, fit or function.A review of the device history record (dhr) for the confidence kit 7cc could not be performed.Lot number unavailable for device.No emerging trends were found requiring further actions.The root cause analysis for the confidence pump is deemed not necessary as no device failures have been identified in this complaint file.The confidence pump was functioning as intended.As there has been no issue identified that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action 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 SPINAL CEMENT SYSTEM
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5646636
• MDR Text Key: 45025791
• Report Number: 1526439-2016-10335
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283907000
• Device Lot Number: HTHBBH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1