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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Cardiac Tamponade (2226)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Event was reported as a result of a clinical study.Identifying information concerning patient and hospital were withheld as a condition of the study.Initial reporter occupation ¿ clinical research coordinator.
Event or Problem Description
It was reported the patient experienced post-operative mediastinal hemorrhage with tamponade following the implantation of sternal fixation plates.The patient had a redo sternotomy with re-exploration of mediastinum with evacuation of clot and washout.No additional patient consequences have been reported.
Event or Problem Description
Further assessment of the event determined that the adverse event was unrelated to the device and no malfunction was alleged to have occurred.Therefore, there is no indication of a reportable event at this time.

• 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: 9591311
• Report Number: 0001032347-2020-00064
• Device Sequence Number: 16897220
• Product Code: HRS
• UDI-Device Identifier: 00841036141028
• UDI-Public: 00841036141028
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/15/2020
• 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