MAUDE Adverse Event Report: BIOMET MICROFIXATION OTOMIMIX CALCIUM PHOSPHATE BONE VOID FILLER 2 GRAMS; CEMENT, EAR, NOSE AND THROAT

Model Number	N/A
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.(b)(6).The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
Event or Problem Description
It was reported the bone cement hardened very fast during a therapeutic stapedotomy.Usually the mixture is stirred for 30-45 seconds and then the mixture hardens within two (2) to four (4) minutes.In this case the mixture hardened after five (5) seconds of stirring.The procedure was completed with no impact to the patient outcome.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.This report is being submitted to update additional information in section d4, h2, h3, h6 and h10, and a correction to d4.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OTOMIMIX CALCIUM PHOSPHATE BONE VOID FILLER 2 GRAMS
• Common Device Name: CEMENT, EAR, NOSE AND THROAT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10999102
• Report Number: 0001032347-2020-00610
• Device Sequence Number: 3617744
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 10/10/2023
• Device Model Number: N/A
• Device Catalogue Number: 7014-3266
• Device Lot Number: 752510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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