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

Catalog Number	74-0004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot) qty: 73-2643 (unknown) qty 1, 73-2412 (unknown) qty 4, 73-2414 (unknown) qty 8, 73-2416 (unknown) qty 8.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
It was reported that following a temporomandibular mandibular joint procedure, a band fracture occurred following a patient cough.The patient was revised approximately one (1) week later, and the surgeon removed and replaced the fractured band, along with the screws.No contributing conditions or additional patient impact was noted.Attempts have been made, and no further information has been provided.
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 corrected: d4, h4.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Visual examination of the returned product identified signs of use with gouges around the outer edges of the inside diameter and one section of the outside diameter.Product identifiers were measured and found conforming to the print specifications.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unable to be confirmed.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: 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: 21334359
• Report Number: 0001032347-2025-00078
• Device Sequence Number: 8441597
• Product Code: HRS
• UDI-Device Identifier: 00888233026604
• UDI-Public: (01)00888233026604(17)291024(10)66849593
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K163007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/14/2025

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: 66849593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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 Age: 72 YR
• Patient Sex: Male