MAUDE Adverse Event Report: BIOMET MICROFIXATION BROWN 15" TI PECTUS BAR; PLATE, FIXATION, BONE

Catalog Number	PT-5236
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# unknown stabilizer; lot# unknown; item# unknown stabilizer; lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that the patient received a pmi pectus bar and two (2) stabilizers on an unknown date.Subsequently, the patient's bar had flipped on an unknown date post-implantation.Patient is scheduled to have a reoperation on a unknown date.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.The following sections were updated/corrected: a1; a2; a3; b4; b5; d1; d2; d4; d6a; e1; g1; g3; g4; g6; h1; h2; h3; h4; h6.E1: full establishment name - (b)(6).Review of the device history records identified no deviations or anomalies during manufacturing.Additional information received does not change the root cause of the previous investigation.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 available at the time of this report.
Event or Problem Description
It was reported that the patient received a pmi pectus bar and two (2) stabilizers on an unknown date.Subsequently, the patient's bar had flipped post-implantation on an unknown date.It was further reported that the patient underwent a revision procedure.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.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information 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: BROWN 15" TI PECTUS BAR
• 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: 16015977
• Report Number: 0001032347-2022-00399
• Device Sequence Number: 5793771
• Product Code: HRS
• UDI-Device Identifier: 00888233060578
• UDI-Public: (01)00888233060578(10)127230
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K061384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/21/2023

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: Health Professional
• Device Catalogue Number: PT-5236
• Device Lot Number: 127230
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/30/2023; 03/03/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/28/2023; 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male