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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the incoming inspection team that foreign substance was found in the sterile packaging.There was no patient involvement.Additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of photographs received.Evaluation of the photographs provided confirmed foreign debris is present inside the sterile packaging.Sterility was not compromised.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is caused by a manufacturing deficiency.No corrective or preventative actions are needed at this time since the complaint was determined not to be a new confirmed quality or manufacturing issue.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 visual examination of the returned products confirmed that they contain foreign debris.Eleven of the 20 sterile pouches from lot #64655319 contain each, one loose blue particle.The loose 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.A change to manufacturing has been implemented to reduce flash and reduce trimming for the mixing bowls.This lot was released for distribution before the implementation of this manufacturing change.This event is non-reportable as there is no serious injury or prior event that has not resulted in serious injury.Additionally, the patient is protected from injury by a standardized process which prevents introduction of non-sterile items to the surgical field.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10226950
• MDR Text Key: 199660734
• Report Number: 0001822565-2020-02381
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00889024376564
• UDI-Public: (01)00889024376564
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• 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: 07/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1