MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM ELONGATED PECTUS STABILIZER; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problems Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930)

Event Date 09/14/2020

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: 0001032347-2020-00501.Medical products: pectus system 11.5in pectus support bar, part# 01-3711-05, lot# 227940.Pectus system elongated pectus stabilizer, part# 01-3801, lot# 407190.Initial report:er: distributor on behalf of facility.The user facility is foreign; therefore, a facility medwatch report will not be available.Report souce: (b)(6).

Event Description

It was reported the patient experienced a foreign body reaction and infection twenty-eight (28) days following implantation of a pectus support bar for the treatment of pectus excavatum.The patient was re-admitted to the hospital and received symptomatic supportive treatment.After three (3) days of treatment, the patient¿s temperature had returned to normal and the purulent discharge from the incision was significantly reduced.The situation resulted in an unspecified psychological impact on the patient.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because of the report of post-operative intervention to preclude serious injury.The device was not returned for investigation as it was reported that the device remains implanted.The treatment described by the sales associate is indicative of an infection rather than a foreign body reaction, which is likely to require explantation of the devices.The dhr was reviewed, and no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this item# 01-3801, lot# 407190.For this part (01-3801) in the previous one year (from the notification date) regarding infection, there is a complaint rate of 0.07% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the infection could not be determined.There are no indications of manufacturing defects.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 Description

This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS SYSTEM ELONGATED PECTUS STABILIZER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10645136
• MDR Text Key: 210370547
• Report Number: 0001032347-2020-00502
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036011093
• UDI-Public: 00841036011093
• Combination Product (y/n): N
• PMA/PMN Number: K981789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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: 01-3801
• Device Lot Number: 407190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2020
• 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