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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: report source (b)(6).Complaint sample was returned and evaluated against the reported event.Visual examination of the 20 units returned found that one (1) unit did not contain any debris, fifteen (15) units contained one piece of loose blue debris, two (2) units contained two pieces of loose blue debris, one (1) unit contained one black elongated fiber of loose debris, and one (1) unit contained one gray clump of loose foreign debris.All loose blue and foreign debris were measured with tappi chart (b)(4) and were found to exceed the allowed 0.60 sq.Mm.Size per zpc 8.400 rev.52.Dhr was reviewed and no discrepancies were found.Investigation has concluded that the root cause is attributed to a manufacturing error.The exact source of the foreign debris cannot be determined but they were likely introduced during the packaging operation.The blue particles likely come from the excess flash generated during the molding process and/or during the trimming of this excess flash.During the packaging operation, the operator failed to identified non-conforming devices.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02476.

Event Description

It was reported that during warehouse inspection, debris was found in the package.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable 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
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10301831
• MDR Text Key: 199682865
• Report Number: 0001822565-2020-02475
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024376664
• UDI-Public: (01)00889024376664
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• 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: 64407672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• 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