MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SPATULA AND POLY BOWL INSERT FOR STAINLESS STEEL MONOMER; DISP MIX BOWL & SPATULA

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for the spatula and polyethylene bowl insert for stainless steel monomer evacuating bowl 5049-10 kit, part number 00504901100 and lot number 62810760, 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 (b)(6) 2016, it was reported from (b)(6) memorial hospital that a spatula and polyethylene bowl insert for stainless steel monomer evacuating bowl 5049-10 kit had a foreign object in the sterile packaging of the device.On 16 aug 2017, a returned product investigation was performed on the spatula and polyethylene bowl insert for stainless steel monomer evacuating bowl 5049-10 kit.The physical evaluation revealed that the returned spatula and polyethylene bowl insert for stainless steel monomer evacuating bowl 5049-10 kit had three loose blue particulates in the sealed packaging, which does not meet zimmer biomet's acceptance criteria.The results of the returned product investigation have confirmed the reported event.The sample size per department sampling plan form, 7.6300/a, 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 (b)(4).¿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 limited access room environmental monitoring and regulations.The materials and methods for sanitizing the clean rooms are performed per 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 per environmentally controlled and clean room gowning procedure used at zimmer (b)(4).While the returned product investigation confirmed that the spatula and polyethylene bowl insert for stainless steel monomer evacuating bowl 5049-10 kit did have three loose blue particulates in the sealed packaging, 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.

Event Description

It was reported that a foreign matter was found in the sterile packaging of the device while inspecting prior to surgery.No adverse events were reported as a result of this malfunction.

• Brand Name: SPATULA AND POLY BOWL INSERT FOR STAINLESS STEEL MONOMER
• Type of Device: DISP MIX BOWL & SPATULA
• 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: 6801993
• MDR Text Key: 83218398
• Report Number: 0001526350-2017-00547
• Device Sequence Number: 1
• Product Code: JDZ
• 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
• Report Date: 08/17/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00504901100
• Device Lot Number: 62810760
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• 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