MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown screws, part# ni, lot# ni.Distributor on behalf of hospital.
Event or Problem Description
It was reported the sternal closure plate fractured post-operatively and was removed in a revision sixteen (16) days following implantation.The bottom plate appeared to be broken when the patient was opened.That patient was not re-plated and was closed with vacuum-assisted closure.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.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.The 74-0004 devices were returned for investigation.One x-plate and one box plate were returned, along with nine unknown screws.One of the screws was still locked inside the box plate and the other eight had been removed.The plates were discolored in a way that indicated they had been implanted.The screws had minor damage on the threads, consistent with what is typically observed on a screw that has been inserted into bone and locked into a plate.The 74-0004 assembly includes two box plates and one x plate along with metal bands and locking mechanisms, however, one box plate is missing.The one box plate and x plate that were returned did not appear to be broken as described in the complaint notification.It is possible that the box plate that was not returned is the alleged broken plate.Lot identification is necessary for review of device history records, lot identification was not provided for item 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: 10529679
• Report Number: 0001032347-2020-00438
• Device Sequence Number: 16949396
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: 00888233026604
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 09/14/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention