MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW CANCELLOUS CROSS-DRIVE LOCKING; 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	11/22/2019
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; 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: 0001032347-2019-00559, 0001032347-2019-00560, 0001032347-2019-00562, 0001032347-2019-00563.Medical products: sternalock 360 multi implant system, part# 74-0004, lot# 743520, sternalock blu system screw cancellous cross-drive locking, part# 73-2414, lot# unk, sternalock blu system screw cancellous cross-drive locking, part# 73-2416, lot# unk, sternalock blu system screw cancellous cross-drive locking, part# 73-2418, lot# unk, sternalock blu system screw cancellous cross-drive locking, part# 73-2716, lot# unk.
Event or Problem Description
It was reported the patient underwent a revision of sternal implants due to bleeding.No additional patient consequences were reported.
Event or Problem Description
Information was received that indicated the re-operation was performed due to bleeding and was not in any way related to a device problem.This is not a reportable event.
Additional Manufacturer Narrative
The following fields were updated: b4 date of this report b5 describe event or problem g7 type of report h2 follow up type h10 additional narratives/data.

• Brand Name: STERNALOCK BLU SYSTEM SCREW CANCELLOUS CROSS-DRIVE LOCKING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9513371
• Report Number: 0001032347-2019-00561
• Device Sequence Number: 16698491
• Product Code: HRS
• UDI-Device Identifier: 00841036141165
• UDI-Public: 00841036141165
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 73-2416
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/09/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention