MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM; 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	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint cmp-(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: 0001032347-2020-00339, 0001032347-2020-00340.Concomitant medical products: 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.Sternalock 360 multi-implant system, part#: 74-0004, lot#: 065990.
Event or Problem Description
It was reported the patient underwent a sternal re-operation due to bleeding.The sternal closure devices were removed and the sternum was closed with new sternal closure devices.Attempts have been made and no further information has been provided.
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.Review of the device history record(s) identified no deviations or anomalies during manufacturing for 74-0004.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: STERNALOCK 360 MULTI-IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10359300
• Report Number: 0001032347-2020-00341
• Device Sequence Number: 971653
• Product Code: HRS
• UDI-Device Identifier: 00841036190668
• UDI-Public: 00841036190668
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151019
• 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
• Report Date (Section B): 03/05/2021

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 Expiration Date: 03/16/2025
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 065990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 03/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention