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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 08/27/2020

Event Type  Injury  

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 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.

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 Description

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

• Brand Name: STERNALOCK 360 MULTI-IMPLANT SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10529679
• MDR Text Key: 206831346
• Report Number: 0001032347-2020-00438
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: 00888233026604
• Combination Product (y/n): N
• PMA/PMN Number: K151019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention