MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. COBALT CEMENT; COBALT HV BONE CEMENT 40GM

Model Number 600-15-000

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/11/2019

Event Type  malfunction  

Event Description

Complaint - the outer packaging is tearing and contaminating the sterile pack.

Manufacturer Narrative

The reason for this complaint was to report, "the outer packaging is tearing and contaminating the sterile pack".This event caused a 2 minute delay in surgery, the agent was not present.There was no adverse event reported and there was another suitable unit available.The items have not been returned for investigational review.Manufacture of cobalt bone cement was recently transitioned from zimmer biomet to osartis.Shipments were received from osartis beginning (b)(6)2018.Product was shipped to djo customers and consignment locations beginning (b)(4)2018.Three customer complaints have been received in september 2018 reporting problems with the new packaging.The outer pouch of the powder is designed to tear open at the top.When the customer tears the package, they may tear the inner sterile pouch resulting in a loss of the sterility of the cement copolymer powder.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.All parts conformed to design and manufacturing specifications at the time of manufacture.No non-conforming material reports were associated with this part.Due to multiple complaints being received in a short amount of time and the possibility of increased patient risk, health hazard evaluation (hhe) (b)(4) will be performed to assess patient risk related to this issue.Corrective and preventive action (capa) (b)(4) has been opened to investigate root cause and determine corrective action.

• Brand Name: COBALT CEMENT
• Type of Device: COBALT HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 8502316
• MDR Text Key: 141743670
• Report Number: 1644408-2019-00279
• Device Sequence Number: 0
• Product Code: LOD
• Reporter Country Code: US
• PMA/PMN Number: K051496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 600-15-000
• Device Catalogue Number: 600-15-000
• Device Lot Number: 820D1D0008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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