MAUDE Adverse Event Report: BIOMET MICROFIXATION 2G OTOMIMIX; CEMENT, EAR, NOSE AND THROAT

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: foreign: united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a sealed box of otomimix was opened, and one of the vials was empty.The empty vial could not be opened as the lid was tightly sealed.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was reported that when a sealed box of otomimix was opened one of the vials was empty.Could not open the empty vial as the lid was tightly sealed.A visual inspection was conducted on the returned product.The product was received open.The bottle containing the powder was full and appears to not have been opened.The jar containing the liquid is empty.Residue can be seen on the threads of the bottle but otherwise, no further signs of residue are present.The lid was unable to be removed from the bottle.There are no signs of residue in the product packaging.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a device design issue.A corrective action has been initiated to address this malfunction.The reported event is confirmed, based on product return.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h4, h6, and h10.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 2G OTOMIMIX
• Common Device Name: CEMENT, EAR, NOSE AND THROAT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17171288
• Report Number: 0001032347-2023-00219
• Device Sequence Number: 15115913
• Product Code: NEA
• UDI-Device Identifier: 00888233025201
• UDI-Public: (01)00888233025201(17)240419(10)750200
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: N/A
• Device Catalogue Number: 7014-3266
• Device Lot Number: 750200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown