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 Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Product is in process of being returned to zimmer biomet for the investigation and a follow-up mdr will be submitted upon completion of the investigation.

Event Description

It was reported that during warehouse inspection, a crease was found in the sealing area of the package.It is unknown if the 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.The following sections were updated/corrected updated: d10; g4; h2; h3; h6.Complaint sample was evaluated against the reported event.Review of the returned products identified no void or peeling of the seals along the crease in 4 out of 20 pouches.Review of the returned products determined that no failure was found as the products are within specification(s).No further investigation or action is required after review.The pouches with the creased seals were determined to be acceptable and therefore 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 additional event information to report at this time.

• 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: 10133179
• MDR Text Key: 194484687
• Report Number: 0001822565-2020-02026
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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: 64655319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1