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

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).Foreign country: (b)(6).Reported event was confirmed with product return.Visual examination determined the unit contained two pieces of loose blue debris and were found to exceed the allowed limit.Review of the device history record(s) identified no deviations or anomalies related to the reported issue during manufacturing.During the packaging operation, the operator failed to identified non-conforming devices.The root cause of the reported issue is attributed to a manufacturing error.This reported event falls within the scope of a previous corrective action.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 through inspection, a team member found that there was foreign substance in the package.No adverse events have been reported as a result of the malfunction.No further event information available at the time of this report.

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Type of Device: ORTHOPEDIC MANUAL 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: 10245960
• MDR Text Key: 199052709
• Report Number: 0001822565-2020-02474
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024376584
• UDI-Public: (01)00889024376584(17)240830(10)64435555
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 64435555
• 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: 07/09/2019
• 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