MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FRONT LOADING CARTRIDGE KIT; EVACUATOR, VAPOR, CEMENT MONOMER

Model Number N/A

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that a hair like substance was found in the sterile packaging of a cartridge kit.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

The product has been received by zimmer biomet on (b)(4).The following sections have been updated/corrected.On (b)(6) 2017, it was reported that a front loading cartridge kit had a hair like substance in the sterile packaging.A returned product investigation was performed on the front loading cartridge kit.The physical evaluation revealed that the returned front loading cartridge kit had a string like foreign object in the packaging.Although the results of the returned product investigation have confirmed the reported event, the sterile barrier was broken by the account prior to returning the device for evaluation.Zimmer biomet inspection procedure as it pertains to sterile non-implantable devices and packaging materials defines that if the particulate is loose then a total of two particles whose individual areas do not exceed 0.60 sq.Mm in size are acceptable.All packing materials and products with heat seals applied during sterile barrier packaging are inspected for particulate before being accepted to stock.Detail sterile components molded and assembled at zimmer biomet surgical, and top level sterile devices are produced and/or packaged in a level ii, limited access room, this room is a controlled and regulated clean environment.The environmental requirements, monitoring frequencies and corrective action process for all the limited access rooms are done, limited access room environmental monitoring and regulations.The materials and methods for sanitizing the clean rooms are performed, housekeeping sanitizing procedure for clean rooms and controlled environments.All employees working or visiting these clean rooms follow established requirements for the dress and personal health habits, environmentally controlled and clean room gowning procedure used at zimmer biomet surgical.While the returned product investigation confirmed that the front loading cartridge kit had a foreign object in the package, it is unknown when the foreign object went in the package because the sterile barrier was broken open prior to being returned for evaluation.For this reason, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: FRONT LOADING CARTRIDGE KIT
• Type of Device: EVACUATOR, VAPOR, CEMENT MONOMER
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7010377
• MDR Text Key: 92533231
• Report Number: 0001526350-2017-00833
• Device Sequence Number: 1
• Product Code: JDY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00506905200
• Device Lot Number: 63476115
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1