MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BLU PRBNT TI BAR 12.5IN; FUNNEL CHEST REMODELLING BAR

Catalog Number	78-6125
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Failure of Implant (1924); Discomfort (2330)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6: exact implant and explant dates are unknown, but the following information was provided: d6a: march 2024.D6b: august 2024.It is unknown whether the device will 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
It was reported that a patient underwent a revision procedure approximately 5 months post implantation due to migration of a pectus bar.The patient had significant heterotopic calcification overlying the sternum which may have been a reaction to the bar.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h11.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.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 5 months post implantation due to rotation of the upper bar.The patient was revised to a single bar placement rather than double.Attempts have been made and no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, b7, d6, e1, g3, g6, h2, h6, h11.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.The following sections were updated: a1, a2, a4, b4, b5, d4, g3, g6, h2, h3, h4, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records and radiographs were provided and reviewed by health care professionals.Review of the available records identified the following: radiologist review the two chest views dated 4 months postop and concluded that they demonstrate pectus implant with two separate bars in place.Of note, on the lateral exam, the sternum is noted superficial to the bars suggesting hardware failure.The ap chest dated 5 months post op demonstrates removal of the superior bar.The implant appears to be appropriately sized on the ap film.No other anatomical or implant failures that would lead to a revision.No heterotopic calcification observed.The medical records showed that 4 months postop, the post-op visit noted protrusion of the chest wall and discomfort, with slight rotation of the upper bar.5 months post op, bar revision with placement of single pectus bar.A definitive root cause cannot be determined.The reported event is confirmed, based on medical records and provided images.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: PECTUS BLU PRBNT TI BAR 12.5IN
• Common Device Name: FUNNEL CHEST REMODELLING BAR
• 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: 20852600
• Report Number: 0001032347-2024-00366
• Device Sequence Number: 12787279
• Product Code: HRS
• UDI-Device Identifier: 00888233032667
• UDI-Public: (01)00888233032667(10)119630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212841
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/31/2025

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: 78-6125
• Device Lot Number: 119630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 01/13/2025; 01/30/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/21/2025; 01/22/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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: 15 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Hispanic
• Patient Race: White