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

Model Number	600-15-000
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Product problem - the tyvek material is tearing when opening to sterile field, during opening of the inner pouch pealing.
Additional Manufacturer Narrative
The reason for this complaint was to report the tyvek material is tearing when opening to sterile field, during opening of the inner pouch pealing.This event occurred away from the patient, the agent was present.There was no delay in surgery and no adverse event was reported and there was another suitable unit available.Manufacture of cobalt bone cement was recently transitioned from zimmer biomet to osartis.Shipments were received from osartis beginning 13 jul 2018.Product was shipped to djo customers and consignment locations beginning 8 aug 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) hhe-2018-00010 will be performed to assess patient risk related to this issue.Corrective and preventive action (capa) ca-01482 has been opened to investigate root cause and determine corrective action.

• Brand Name: COBALT BONE CEMENT
• Common Device Name: COBALT HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8417259
• Report Number: 1644408-2019-00182
• Device Sequence Number: 2227706
• Product Code: LOD
• UDI-Device Identifier: 00190446138006
• UDI-Public: (01)00190446138006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: 600-15-000
• Device Catalogue Number: 600-15-000
• Device Lot Number: 820D2D0011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1