MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK® 360 STERNAL CLOSURE SYSTEM; SL360 MULTI-IMPLANT SYSTEM

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem No Code Available (3191)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

It is unknown at this time if screws were implanted and removed.Review of device history records show the lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.(b)(4).

Event Description

It was reported the patient¿s original surgery was on (b)(6) 2017 and the patient's chest was left open.The chest closure surgery was performed on (b)(6) 2017.During the chest closure surgery, the first 360 kit that was implanted failed and had to be removed and replaced.The replacement kit worked as intended.Additional information was requested but not received at this time.

• Brand Name: STERNALOCK® 360 STERNAL CLOSURE SYSTEM
• Type of Device: SL360 MULTI-IMPLANT SYSTEM
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6803620
• MDR Text Key: 83019104
• Report Number: 0001032347-2017-00676
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 557930
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention