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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/08/2019
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 device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00051, 0001032347-2020-00052.Concomitant medical products: sternalock blu system plate, 8 hole jl-plate, part# 73-2645, lot# unk, sternalock blu system plate, 8 hole x, part# 73-2623, lot# unk, unknown screws, part# unk, lot# unk.Event reported by zimmer biomet employee on behalf of a clinical research study.As a condition of the study, the researchers would not release identifying hospital or patient information.Occupation: (b)(6).
Event or Problem Description
It was reported a patient experienced a wound infection following sternal closure.In (b)(6) 2019, the patient was closed with three plates after an unspecified cardiac event.In (b)(6) 2019, a slight separation and an infection was noted in the wound which was resolved with oral medication keflex.No additional patient consequences were reported.
Event or Problem Description
Further assessment of the event determined that the adverse event was not related to the device and there is no alleged malfunction.Therefore, there is no indication of a reportable event at this time.
Additional Manufacturer Narrative

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 8 HOLE X
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9577873
• Report Number: 0001032347-2020-00052
• Device Sequence Number: 11570613
• Product Code: HRS
• UDI-Device Identifier: 00841036141028
• UDI-Public: 00841036141028
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: 73-2623
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 06/11/2020
• 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