MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM DEFAZIO 13 TI PECTUS BAR; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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: 0001032347-2020-00127.Concomitant medical products: pectus system defazio 13 ti pectus bar, part# pt-2872, lot# 885100.Pectus system defazio 13.5 ti pectus bar, part# pt-2873, lot# 885110.
Event or Problem Description
It was reported that a patient underwent a revision surgery approximately one year following implantation of two custom pectus bars.The patient was involved in a car accident and the bars needed to be re-positioned.The re-operation was successful and the patient is doing well.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed as there was a revision surgery.The pectus bars remain implanted and were not returned for investigation.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.The most likely underlying cause of this complaint is patient condition.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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS SYSTEM DEFAZIO 13 TI PECTUS BAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9746472
• Report Number: 0001032347-2020-00126
• Device Sequence Number: 14067613
• Product Code: HRS
• UDI-Device Identifier: 00841036261436
• UDI-Public: 00841036261436
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K061384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PT-2872
• Device Lot Number: 885100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR