MAUDE Adverse Event Report: BIOMET MICROFIXATION SL360 MULTI-IMPLANT SYSTEM; STERNAL FIXATION DEVICE

Catalog Number	74-0004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 2 weeks post implantation due to a broken sternal band, which had broken at the bottom portion of the sternum.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned.A visual inspection was conducted on the customer provided pictures.The pictures show a clear fracture of the band.A determination cannot be made as to what caused the band to fracture.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: ¿sternalock 360 band broke at bottom portion of the sternum.Attached to 4 hold box plate.The sternum was approximated with wire.Wire pulled through sternum on opposite side of where band broke.¿ per the surgeon: ¿the band was broken.Screws all still in place and a good length.Bilateral transfers fracture with about 1.5cm separation on the left, 1cm on the right.The other plates/wires all intact, it was like the lower 1/3 of his sternum just broke off.Had to do double robicsek bilaterally and ended up plating the costosternal junctions x3 on the left as robicsek reinforcement and a pec flap.The wire i had on the lower 1/3 had pulled through the right side of the sternum, the band had broken, and plate pulled through the left.¿ a definitive root cause cannot be determined.The reported event is confirmed, based on examination of the provided photos.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: SL360 MULTI-IMPLANT SYSTEM
• Common Device Name: STERNAL FIXATION DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17379659
• Report Number: 0001032347-2023-00289
• Device Sequence Number: 15052632
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: (01)00888233026604(17)280426(10)65910371
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74-0004
• Device Lot Number: 65910371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male