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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02973, 0001822565-2020-02974, 0001822565-2020-02975.Visual evaluation of the returned products confirmed the presence of loose blue particles inside the sealed pouch for three of the twenty units.The three units contains each one loose blue particle.All the blue particles have a size greater than 0.60 sq.Mm as measured with tappi chart, which is not acceptable.The complaint is confirmed complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.The likely condition of the three units when they left zimmer biomet control is considered non-conforming.The blue particles likely came from the excess flash generated during the molding process of the mixing bowl and/or during the trimming of this excess flash.The root cause of the reported issue is attributed to a manufacturing issue.The following actions were previously initiated to address this issue, a change to manufacturing has been implemented to reduce flash and reduce trimming.The reported product was manufactured before the implementation of this manufacturing change.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

It was reported that there was debris in the sterile packaging.No adverse events have been reported as a result of the malfunction.Additional information on the reported event is unavailable.

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Type of Device: SURGICAL INSTRUMENT
• 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: 10442163
• MDR Text Key: 204012410
• Report Number: 0001822565-2020-02974
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024376564
• UDI-Public: (01)00889024376564
• 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,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2020

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: 08/10/2020
• Device Model Number: N/A
• Device Catalogue Number: 00504901100
• Device Lot Number: 64435604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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