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

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

It was reported after the surgeon inserted all three implants, approximating the sternal halves, during the third step of locking the cam-lock mechanism and cutting, the tension band from the implant/tensioning device and plate/band connection opened.The surgeon removed the sternalock 360 implant since it was damaged and implanted sternalock blu plates and screws.No screws were inserted before the removal of the implant.No additional patient consequences were reported.

Event Description

This report is being submitted to report the results of the device evaluation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned in a biohazardous condition.Dried blood and tissue were evidence of an insertion attempt the tower was returned with the band fed through and cut indicating that step three was completed successfully.The t handle that is pulled up on in step four was pulled up all the way when the product was evaluated.The remaining portion of the band was returned still fed into the plate.The locking device on one end of the band still remains in the fully locked position.There is damage to the opposite end of the band which is evident of the locking mechanism being fully engaged on the band and the band being pulled through with the locking mechanism still fully engaged.The t handle was returned not pulled up fully; however it could not be confirmed if this is the position the surgeon left it or it settled into that position during the return and sterilization process.If this handle is not fully engaged, then the sternalock plate that is attached to the tower will not fully release from the tower and may contribute to excessive force being applied to the band while trying to disengage the plate, causing the band to pull through the locking mechanism.Another contributing factor could be a high patient bmi.The instructions for use (ifu) for this product contains instructions for proper usage of the system in the sections titled directions for use of a single sternalock® 360 device.Device history record (dhr) was reviewed and no discrepancies were found.There are no indications of manufacturing defects investigation results concluded that the reported event was due to excessive force applied to the band beyond what it was designed to encounter, causing the band to pull through the locking mechanism.A summary of the investigation has been sent to the complainant.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.

• 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: 7538480
• MDR Text Key: 109062666
• Report Number: 0001032347-2018-00293
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK151019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 332210
• Other Device ID Number: (01)00841036190668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention