MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM SMOOTH PECTUS BAR 25.4CM (10IN)(L); PLATE, FIXATION, BONE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, associated reports: 0001032347-2020-00475, 0001032347-2020-00476.Concomitant medical products: pectus system smooth pectus bar 25.4cm (10in)(l), part# 01-3710-p, lot# 787280, pectus system smooth pectus bar 25.4cm (10in)(l), part# 01-3710-p, lot# j3839223, pectus system smooth pectus bar 27.9cm (11in)(l), part# 01-3711-p, lot# j3805905.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).

Event Description

It was reported the patient developed a pneumothorax and underwent emergency surgery forty-three (43) days following implantation of four (4) pectus support bars, fourteen (14) days following a revision to correct device migration of the pectus support bars, and one (1) day following an additional surgery due to pneumothorax.The position of devices was not modified during the emergency surgeries for the pneumothorax.It was reported that no further information is available.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined the initial report was forwarded in error and should be voided.This report was found to be a duplicate/continuation of the event in report: 0001032347-2020-00478.

Event Description

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

• Brand Name: PECTUS SYSTEM SMOOTH PECTUS BAR 25.4CM (10IN)(L)
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10606617
• MDR Text Key: 209182693
• Report Number: 0001032347-2020-00474
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036076221
• UDI-Public: 00841036076221
• Combination Product (y/n): N
• PMA/PMN Number: K972420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3710-P
• Device Lot Number: 787280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR