MAUDE Adverse Event Report: DEPUY SYNTHES SPINE HIGH VISC SPINAL CEMENT, 11CC; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901000

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

The cement set within 1 minute after mixing the cement in the cement mixing reservoir instead of the 10min window period.

Manufacturer Narrative

(b)(4).Visual examination revealed an unspecified small amount of solidified cement still attached to the confidence t-handle shaft.Additionally, it was noted that the cement was not fully transferred into the glass cement reservoir.Cement became solidified halfway inside the cement reservoir.Further evaluation indicated that the cement reservoir was not screwed in correctly onto the transfer adapter.The cement reservoir was slightly angled.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause for the confidence cement setting too quickly cannot be positively determined.However, a possible root cause may be due to the environment of the storage location or use of the cement.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 were found, 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: HIGH VISC SPINAL CEMENT, 11CC
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): TEKNIMED SAS; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5247033
• MDR Text Key: 32042808
• Report Number: 1526439-2015-10968
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 183901000
• Device Lot Number: 043D14311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• 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