MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM PLATE, 4 HOLE L-PLATE 100 DEGREES; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00412, 0001032347-2020-00413, 0001032347-2020-00414, 0001032347-2020-00415.Medical products: sternalock blu system plate, 4 hole l-plate 100 degrees, part# 73-2643, lot# ni; sternalock blu system screw, cancellous cross-drive locking 2.4 x 10mm, part# 73-2410, lot# ni; sternalock blu system screw, cancellous cross-drive locking 2.4 x 12mm, part# 73-2412, lot# ni; sternalock blu system screw, cancellous cross-drive locking 2.4 x 14mm, part# 73-2414, lot# ni; sternalock blu system screw, cancellous cross-drive locking 2.4 x 16mm, part# 73-2416, lot# ni.
Event or Problem Description
It was reported the patient underwent a revision of sternal closure plates and screws due to bleeding.The patient was closed with new sternal closure devices.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the patient underwent a revision due to bleeding one (1) day following closure with sternal plates and screws.It was reported the surgeon did not use the plate configuration recommended by the ifu in the original implantation surgery.One (1) out of the original three (3) plates were replaced in the revision.It was reported that no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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.This report is being submitted to update additional information in section h2, h3, h6 and h10.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 4 HOLE L-PLATE 100 DEGREES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10483858
• Report Number: 0001032347-2020-00411
• Device Sequence Number: 4093325
• Product Code: HRS
• UDI-Device Identifier: 00888233000987
• UDI-Public: 00888233000987
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2021

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: 73-2643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 02/10/2021; 03/03/2021
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 03/02/2021; 03/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention