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

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It is reported the surgeon had a few wires and had the sternalock 360 implants in at the manubrium and body of the sternum.When finalizing the last plate the band would not pass through because the slot was solid (not machined out).The surgeon wanted to use the proper construct as recommended, however there was only one implant kit present at the time.The surgeon opted to remove the sternalock 360 implants and complete the procedure using wires (non-zimmer biomet product).There was a four minute surgical delay and no injury to the patient.

Manufacturer Narrative

A visual inspection of the returned product found that only one band was returned with no original packaging.Removing the part from the bag and inspecting it can be seen that the band window on the locking mechanism body is only half way machined through and the finger slot where the cam slides into lock is missing from the body.These missing features will cause the part to be un-usable; therefore the complaint is confirmed.The most likely cause of the band window being missing is due to the tooling breaking during machining, and this piece being missed during the machine operators inspection of the parts ran with a broken tool.The device history record was reviewed and no deviations were identified.

• 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: 6723919
• MDR Text Key: 80378014
• Report Number: 0001032347-2017-00563
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 557730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention