MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISPOSABLE MIXING BOWL AND SPATULA; CEMENT MIXER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Product is in process of being returned for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that product was found to have a crease in the sealing area.It is unknown if sterility of the product has been compromised.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Visual evaluation of the returned product confirmed the presence of a crease in the seal.However, there is no open path or channel through the seal.Sterility was not breached.No other damage was noted.Therefore the product is acceptable per zpc 8.400 rev.52 acceptance criteria [sterility of the pouch is not compromised].As the packaging was determined to be acceptable per zpc 8.400 rev.52 acceptance criteria [sterility of the pouch is not compromised], a review of the device history records and a complaint history review was not performed per wi040006 rev.10 review of the packaging determined that no failure was found as the product is within specification and is considered to be not reportable.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Type of Device: CEMENT MIXER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10066352
• MDR Text Key: 192216251
• Report Number: 0001822565-2020-01768
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024379718
• UDI-Public: (01)00889024379718
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00504901100
• Device Lot Number: 64633897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1