MAUDE Adverse Event Report: BIOMET MICROFIXATION 2G OTOMIMIX; CEMENT, STOMAL APPLIANCE, OSTOMY

Model Number	N/A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the product hardened very quickly and did not become homogenous.The customer reported a problem when mixing the product during preparation of a therapeutic ear implant procedure.There was no significant surgical delay, the intended procedure was completed with another container of the same product, and this did not impact the outcome of the procedure.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.For all 2g otomimix (part# 7014-3266) in the previous year (from the notification date), there is a complaint rate of 0.16%; as this overall complaint rate is already below the occurrence rate of this failure mode (0.5%), no further review is necessary.No product was returned and no functional tests or inspections could be performed.There are no indications of manufacturing defects.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: 2G OTOMIMIX
• Common Device Name: CEMENT, STOMAL APPLIANCE, OSTOMY
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8612558
• Report Number: 0001032347-2019-00278
• Device Sequence Number: 1808239
• Product Code: NEA
• UDI-Device Identifier: 00841036141943
• UDI-Public: 00841036141943
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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: 11/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 7014-3266
• Device Lot Number: 402320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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