MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM SMOOTH PECTUS BAR 27.9CM (11IN)(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 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (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, please see associated reports: (b)(4) and (b)(4).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.(b)(6).

Event Description

It was reported the patient developed a pneumothorax and underwent emergency surgery forty-two (42) days following implantation of four (4) pectus support bars and fourteen (14) days following a revision to correct device migration of the pectus support bars.The position of devices was not modified during the emergency surgery for the pneumothorax.It was reported that no further information is available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b3; b4; b5; g3; g6; h1; h2 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.

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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.

Event Description

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

• Brand Name: PECTUS SYSTEM SMOOTH PECTUS BAR 27.9CM (11IN)(L)
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10608064
• MDR Text Key: 209236208
• Report Number: 0001032347-2020-00480
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036076214
• UDI-Public: 00841036076214
• 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,Followup
• Report Date: 07/01/2021

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 Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3711-P
• Device Lot Number: J3805905
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 04/01/2021; 06/29/2021
• Supplement Dates FDA Received: 04/27/2021; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR