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

Model Number N/A

Device Problem Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

The distributor reported the tensioner remains implanted; therefore it will not be returned for an evaluation and the complaint will be considered non-verifiable.The product identity was not confirmed as a result of the part not being returned.The most likely underlying cause of the complaint could not be determined as the product was not returned and no functional tests could be performed.The instructions for use for this product contains instructions for proper usage of the system in the sections titled directions for use of a single sternalock® 360 device.The device history records of this product's reported lot was reviewed and no non-conformance was identified that would cause or contributed to the reported event.There are no indications of manufacturing defects.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.

Event Description

The distributor reported that the band of the sternalock 360 deployed between steps one and two while the surgeon was attempting to approximate the sternum.The tensioner came loose from the plate/ band while pulling to reduce the sternum and was reassembled in order to complete the procedure.

• 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: 6453802
• MDR Text Key: 71528199
• Report Number: 0001032347-2017-00255
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2018
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 261740
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• 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