MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BLU STABILIZER TI; PLATE, FIXATION, BONE

Catalog Number	78-8020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint (b)(4).D10: medical products.Item unk, lot unk; unknown pectus bar.Item unk, lot unk; unknown pectus bar.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
It was reported a patient underwent a nuss procedure followed by and additional surgery due to the bar flipping.Subsequently, the patient underwent an i&d of a pectus wound with placement of a wound vac and antibiotic therapy.All implants remain in place.Attempts have been made and 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, d4, d10, g3, g6, h2, h3, h4, h6, h11.D10: pectus blu prbnt ti bar 12in cat# 78-6120 lot#29210.Pectus blu prbnt ti bar 12in cat# 78-6120 lot#29210.Pectus blu stabilizer ti cat# 78-8020 lot#28125.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 were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a nuss procedure followed by an additional surgery approximately 1 week later, due to the bar flipping.Approximately 1 month post op, the patient returned to surgery for incision and drainage of pectus wound.Treated with 4 day course of iv ceftriaxone and wound vac therapy.A definitive root cause cannot be determined.This is a non-sterile product related infection and is not considered a zb issue as it labeled as nonsterile and presumed to be sterilized and readied elsewhere; therefore, products are not identified as the source or contributing to the reported infection.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The reported event is confirmed, based on medical records.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: PECTUS BLU STABILIZER TI
• 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: 21503968
• Report Number: 0001032347-2025-00101
• Device Sequence Number: 7901937
• Product Code: HRS
• UDI-Device Identifier: 00888233032834
• UDI-Public: (01)00888233032834(10)28125
• 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: 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): 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?: No
• Device Catalogue Number: 78-8020
• Device Lot Number: 28125
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic
• Patient Race: White