MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 12MM; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage/Bleeding (1888)

Event Date 08/21/2020

Event Type  Injury  

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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00411, 0001032347-2020-00412, 0001032347-2020-00413, 0001032347-2020-00414, 0001032347-2020-00415.Concomitant of 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 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event 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.

Event Description

No further event information available at the time of this report.

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.

• Brand Name: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 12MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10483885
• MDR Text Key: 205460789
• Report Number: 0001032347-2020-00413
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888233000888
• UDI-Public: 00888233000888
• Combination Product (y/n): N
• PMA/PMN Number: K110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2412
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention