MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. COMPACT VACUUM CEMENT MIXING SYSTEM; COMPACT VACUUM CEMENT MIXING SYTEM

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was initially reported for the compact vacuum cement mixing system that it had human hair stuck in the tubing inside the sterile package.Additional information received february 14, 2017 explained that this was noticed prior to surgery, and there was no patient or user harm.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for the compact vacuum cement mixing system, part number 00504903501 and lot number 63476231, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 09 feb 2017, it was reported from central (b)(6) hospital that a compact vacuum cement mixing system had a human hair stuck in the tubing inside the sterile packaging.On 21 feb 2017, a returned product investigation was performed on the compact vacuum cement mixing system.The physical evaluation revealed that the returned package had a human hair wrapped with the twist tie around the tubing.The results of the returned product investigation, however, cannot confirm the reported event because it is unknown where the hair came from since the packaging was already opened by the account.The hair did not meet zimmer biomet's acceptance criteria.The sample size per department sampling plan form, dictates that the sampling size for qa inspection for this product must be at least 19.No non-conformances were found during the qa inspection process for this lot of 640 units.¿final qa inspection¿ and ¿particulate inspection¿ is a visual comparison inspection of the size of the particle against a ¿dirt estimation chart¿ using the tappi (t213 and t437) test methods.These inspection steps define the following parameters for particulate inspection: visually examine the package without opening.Inspect at a distance of 12 to 18 inches.Inspect each pouch for up to 10 seconds.Zimmer biomet inspection procedure ¿packaging materials inspection¿ 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 in accordance with the procedure, 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 dover.While the returned product investigation did reveal that a hair was inside the package of the compact vacuum cement mixing system, it is unknown where the hair came from because the packaging was already opened by the account.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: COMPACT VACUUM CEMENT MIXING SYSTEM
• Type of Device: COMPACT VACUUM CEMENT MIXING SYTEM
• 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: 6375859
• MDR Text Key: 69271225
• Report Number: 0001526350-2017-00106
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00504903501
• Device Lot Number: 63476231
• Other Device ID Number: (01)00889024374843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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