MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore a facility medwatch report will not be available.
Event or Problem Description
It was reported that two plates which were fixated to the patient's sixth and seventh ribs fractured post-implantation.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 confirmed by review of scans and xrays.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The most likely underlying cause of the fracture cannot be determined from the information and images provided.There are no indications of manufacturing defects.For this part (76-2603) and the previous one year (from the notification date), there was a complaint rate of 0.14% which is no greater than the occurrence listed in the application fmea.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: RIBFIX BLU SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8567017
• Report Number: 0001032347-2019-00258
• Device Sequence Number: 2220597
• Product Code: HRS
• UDI-Device Identifier: 00841036197964
• UDI-Public: 00841036197964
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K162974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2019

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 Model Number: N/A
• Device Catalogue Number: 76-2603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 08/11/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS CATALOG#: NI LOT#: NI