MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11 CC; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283910000

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pump cracked and sprayed sterile water onto the field.(b)(6) 2015, dr lawhorne was doing a vertbral body augmentation (vba).Cement had been mixed and spinal needles placed.As dr lawhorne was delivering the cement, the plastic housing of the delivery pump cracked.This caused pressure to be released and spraying of sterile water contained in the housing.Another kit was presented and case completed with no adverse effects to the patient or effectiveness of clinical result.

Manufacturer Narrative

The confidence spinal system was returned for evaluation.Visual examination of the complaint sample revealed that the confidence pump body cracked at the distal tip.The crack initiated at tip and propagated to a length of approximately 2.5 inches.3 potential causes of failures were identified and evaluated.Testing and verifications were performed and meet expectations.A review of the dhr found no issues that could have caused or contributed to the reported event.Complaint trend analysis found no related complaints.The root cause cannot be determined based on the provided information or returned sample.Based on the evaluation, it can be concluded that this complaint was an isolated incident and was likely a result of unknown external factors.Based on the results of the investigation, no further complaint action is 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 PLUS KIT SPINAL CEMENT SYSTEM 11 CC
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5278352
• MDR Text Key: 33047254
• Report Number: 1526439-2015-11037
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283910000
• Device Lot Number: HTFB9D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• 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
• Patient Age: 79 YR