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

Catalog Number 283913000

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 08/05/2016

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

Physician reported that cement has being frozen too quickly.Moreover according to physician there were some pieces into cement.To complete procedure physician used another one product.No injury for the patient reported.

Manufacturer Narrative

(b)(4).The needleless confidence kit (product code: 2839-13-000, lot number: unknown) was not returned to the complaints handling unit (chu).The additional information provided has stated that no sample will be returned.The status of the sample has been listed as ¿none.¿ a review of the device history record (dhr) could not be performed on the needleless confidence kit (product code: 2839-13-000, lot number: unknown) as no lot number was provided.Since this kit was not returned, no lot number could be taken directly from the sample.Without the lot number, no review of its manufacturing records could be completed.No emerging trends were found requiring further actions.Without the kit, we are unable to confirm the reported issue or identify the root cause.No corrective and preventive action (capa) is necessary at this time as no issues could be identified in the manufacturing or release of this product as the lot number was not reported.No patient harm or surgical delay.In the event of a recurrence, other kits would be available.Therefore, this complaint 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.Device was not returned for evaluation.

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 5914098
• MDR Text Key: 53493082
• Report Number: 1526439-2016-10625
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 283913000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: No
• 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