MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283913000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

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

Cement was applicated, but no typically cement-picture was seen at the fluoro - only a little shadow of possible cement around the screws in the vertebral bone.Approx.2 ml cement per screw were applicated.4 screws in total.Cement was applicated, but no typically cement-picture was seen at the fluoro - only a little shadow of possible cement around the screws in the vertebral bone.Approx.2 ml cement per screw were applicated.4 screws in total.

Manufacturer Narrative

Product complaint # (b)(4).One (1) confidence kit, no needles was not returned to the customer quality unit (cqu).No samples are expected to be returned.The contact stated that the product was discarded.Thus, an investigation will be based on a no sample device evaluation.Previously product issue assessment was opened to further investigate the confidence cement issue.The preliminary root cause for this issue was attributed to supplier error.The raw materials for the cement were not mixed properly during manufacturing, and subsequent testing of the material was missed.The allegation has previously been investigated as part of the capa and escalated to field action.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7084303
• MDR Text Key: 94937637
• Report Number: 1526439-2017-50042
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: 10705034209630
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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: Health Professional
• Device Catalogue Number: 283913000
• Device Lot Number: 147555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/11/2018
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1526439-12-15-2017-001-R
• Patient Sequence Number: 1