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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Lot number - possible lot numbers are: 016570, 582090, 402320.Expiration date - lot 016570: june 2, 2020; lot 582090: may 2, 2020; lot 402320: november 1, 2019.Health professional - initial reporter has an email associated with a hospital.Occupation - initial reporter has an email associated with a hospital, no other information.Initial reporter also sent report to fda - the user facility is foreign; therefore a facility medwatch report will not be available.Report source - (b)(6).Device manufacture date - lot 016570: june 2, 2018; lot 582090: may 2, 2018; lot 402320: november 1, 2017.Additional narratives/data - 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 customer has had various problems with the mix.Either the mix has been too loose or too dry but still not hardened after 10 min.Up to two times the customer has used up to 3-4 products to get it right while the patient has been in narcosis.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.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 malfunction has caused a delay exceeding 30 minutes.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
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.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.

• 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: 8460636
• Report Number: 0001032347-2019-00188
• Device Sequence Number: 344613
• Product Code: NEA
• UDI-Device Identifier: 00841036141943
• UDI-Public: 00841036141943
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K042516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7014-3266
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 07/29/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/01/2019; 07/31/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention