MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM 8 HOLE STRAIGHT PLATE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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 the patient underwent an open reduction and internal fixation of three ribs following a traumatic injury.During recovery, the patient sustained additional trauma (kick to his ribs) and developed an infection.The infection was localized, however because two of the three plated ribs had healed and the patient was considered non-compliant, the surgeon made the decision to remove all plates and screws.No additional patient consequences were reported.
Additional Manufacturer Narrative
The reported event is considered confirmed as a revision was performed.No product was returned therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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: RIBFIX BLU SYSTEM 8 HOLE STRAIGHT PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8544067
• Report Number: 0001032347-2019-00244
• Device Sequence Number: 1731081
• Product Code: HRS
• UDI-Device Identifier: 00841036184308
• UDI-Public: 00841036184308
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 76-2601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 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
• Concomitant Medical Products and Therapy/Usage Dates: BIOMET SCREW CATALOG #: NI, LOT #: NI; BIOMET SCREW CATALOG #: NI, LOT #: NI
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention