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	10/26/2020
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.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported the bone filler mixture did not set during preparation.When mixed, the proportion of the two components did not seem adequate as there was not enough liquid.The product was not used.It was reported that no further information was available.
Additional Manufacturer Narrative
Upon further review, it was determined that this is not a reportable event.No patient harm was caused by the malfunction.Following a review of complaint history, the malfunction has not resulted in patient harm in the past.
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: 10856553
• Report Number: 0001032347-2020-00571
• Device Sequence Number: 13599021
• Product Code: NEA
• UDI-Device Identifier: 00841036141943
• UDI-Public: 00841036141943
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 07/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 7014-3266
• Device Lot Number: 494890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 06/17/2021
• 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