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

Catalog Number	74-0004
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial sternal fixation procedure, a fixation system was used to approximate the patient¿s sternum.Three plates and multiple screws were implanted, with one plate placed in the manubrium, another in the sternal body, and a third in the distal body.During implantation, the tower of the middle plate was dislodged but reattached before achieving the desired compression and locking the crimp in the middle plate.The patient later underwent reoperation due to sternal dehiscence approximately one (1) week later.Upon incision, the middle plate was found fractured along the sternotomy line, the band appeared buckled, the proximal plate exhibited screw pull-out, and the distal plate showed band pull-through on the bone.All hardware was removed, and the sternum was reclosed using double wires and additional plates.The patient is expected to recover fully.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): unknown 360 screw (unknown).Associated product information: unknown 360 screws (unknown); quantity (b)(4).The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.The reported event is confirmed, based on provided photos.No product was returned.A visual inspection was conducted on the customer-provided pictures.When zoomed in a clear fracture of the plate occurred both on the top and the bottom of the plate.A determination cannot be made as to what caused the plate to fracture.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: STERNALOCK 360 SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 21148343
• Report Number: 0001032347-2025-00013
• Device Sequence Number: 21147917
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: (01)00888233026604(17)280716(10)66108149
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K163007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: Lay User/Patient
• Device Catalogue Number: 74-0004
• Device Lot Number: 66108149
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male