MAUDE Adverse Event Report: BIOMET MICROFIXATION TITANIUM PECTUS ELONGATED STAB; FUNNEL CHEST REMODELING BAR

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: novak 13.5" ti pectus bar cat# pt-4004 lot#ni.Titanium pectus elongated stab cat# 01-3802 lot#ni.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2021 - 00204.0001032347 - 2021 - 00206.

Event Description

It was reported that a pectus bar and two stabilizers were explanted approximately two months postimplantation due to dislocation of the bar from the stabilizer.The surgeon plans on reinsertion in the near future.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for the stabilizers.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the chest demonstrate postoperative changes from reconstruction of a pectus excavatum procedure with dislodgment of the pectus bar from the stabilizer on the left side of the patient.The overall fit of the implant is appropriate.No correlating factors can be identified for the dislodgement of the pectus bar from the stabilizer on the left side of the patient.The patient op notes were reviewed: the patient was diagnosed with having severe pectus excavatum.She had worsening shortness of breath and chest discomfort over a period of several months prior to the procedure.She had no significant symptoms since childhood and did not consider surgical repair until now.More recently, she has been unable to do her active exercises because of shortness of breath and chest discomfort.A definitive root cause cannot be determined.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 Description

No further event information is available at the time of this report.

• Brand Name: TITANIUM PECTUS ELONGATED STAB
• Type of Device: FUNNEL CHEST REMODELING BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11731978
• MDR Text Key: 247523477
• Report Number: 0001032347-2021-00205
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K061384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOVAK 13.5 TI PECTUS BAR CAT#PT-4004 LOT#029680; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR