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

Catalog Number	78-8020
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.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 that the patient underwent an initial pectus repair procedure.Approximately two months post-implantation, displacement of the bar occurred, and the product migrated into the chest cavity.During reoperation, the device was repositioned, and the procedure was completed successfully.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: a4, b5, b7, d6a, e1, e2, e3, g3, h1, h2, h6 and h10.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.
Event or Problem Description
It was reported that the patient underwent an initial pectus repair procedure.Approximately two months post-implantation during a routine checkup, the surgeon discovered displacement of the bar had occurred, and the product migrated into the chest cavity.The patient experienced discomfort due to the event.Therefore, the patient underwent a procedure to reposition the bar.During reoperation, the device was repositioned, and the procedure was completed successfully without any additional devices being implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: b1, h1, h2, h6, h10, and h11.The complaint could not be confirmed as no product was returned or pictures provided.Visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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.
Event or Problem Description
No further event information 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: 24313951
• Report Number: 0001032347-2026-00037
• Device Sequence Number: 4837655
• Product Code: HRS
• UDI-Device Identifier: 00888233032834
• UDI-Public: (01)00888233032834(11)250729(10)67506512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 78-8020
• Device Lot Number: 67506512
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 04/14/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/24/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 65 KG