MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT; 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	05/25/2020
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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00286, 0001032347-2020-00287.Medical products: sternalock blu system plate, 8 hole straight, part# 73-1952, lot# ni.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 14mm, part# 73-2414, lot# ni.
Event or Problem Description
It was reported the patient underwent a sternal revision due to bleeding.The existing sternal closure plates and screws were removed and replaced with new sternal closure plates and screws.The patient is supported on ecmo.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered confirmed because a revision surgery was reported.The devices were not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or visual evaluations could be conducted.The dhr could not be reviewed due to the lot number remaining unknown.There are no indications of manufacturing defects.For this part (73-1952) in the previous one year (from the notification date), the full complaints history was reviewed and there is a complaint rate of (b)(4).Because this overall complaint rate is already below the occurrence rate of this failure mode, no further review is necessary.The most likely underlying cause of the complaint 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10212711
• Report Number: 0001032347-2020-00286
• Device Sequence Number: 16785412
• Product Code: HRS
• UDI-Device Identifier: 00841036141004
• UDI-Public: 00841036141004
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 73-1952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: Hospitalization; Required Intervention