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

Catalog Number 283913000

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

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

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Udi: (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 delivery hydraulic device exploded twice.One (b)(6) and again to my notification on (b)(6).

Manufacturer Narrative

One (1) confidence kit no needles [product code: 2839-13-000] was returned to the customer quality unit (cqu).For evaluation.Visual examination of the complaint sample revealed that the confidence pump body cracked at the distal tip, where the flex tube exits the part.The crack initiated at the tip and propagated to a length of approximately 2.5 inches.Additionally, it should be noted that the crack formed through the middle of the pump body approximately 70-80 degrees from the parting line.At manufacturing the pump undergoes a 100% high pressure testing in-process where the safety relief valve is actuated ensuring proper functionality and prevention of pump cracking.A definitive root cause cannot be determined at this time.A potential root cause for this failure is that the safety relief valve did not actuate properly to relieve pressure, and that the pump body inner diameter may have been too small.Without the lot number manufacturing record review could not be completed.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 KIT SPINAL CEMENT SYSTEM - NO NEEDLE
• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6347240
• MDR Text Key: 67934814
• Report Number: 1526439-2017-10133
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283913000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• 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: Unknown
• Patient Sequence Number: 1