MAUDE Adverse Event Report: BIOMET MICROFIXATION SL360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number N/A

Device Problems Fracture (1260); Migration (4003)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet microfixation sternal screws, catalog #: ni, lot #: ni.Therapy date: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported there was a revision due to the bottom band of the implant breaking and the middle band tearing through the sternum.The surgeon explanted the devices and the patient was closed with a figure of eight wire technique.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 reported event is considered confirmed as a revision was reported.The explanted product was not returned and therefore could not be visually evaluated or functionally tested.No x-rays, scans, surgical reports, or photographs were provided.The instructions for use (ifu) for this product states in the section titled possible adverse effects: poor bone formation, osteoporosis, osteolysis, osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.Nonunion or delayed union which may lead to breakage of the implant.Migration, bending, fracture or loosening of the implant.Decrease in bone density due to stress shielding.Necrosis of bone.Inadequate healing.It also states instructions for proper operation of this product in the section titled directions for use of a single sternalock® 360 device.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

This follow-up report is being submitted to relay additional and/or corrected information.

• Brand Name: SL360 MULTI-IMPLANT SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8078435
• MDR Text Key: 127405760
• Report Number: 0001032347-2018-00796
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K163007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention