MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 11" PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient identifier: first initial: unknown; second initial: (b)(6).Concomitant medical product: biomet microfixation elongated pectus stabilizer catalog# 01-3801, lot# ni.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2019-00271.
Event or Problem Description
It was reported that the patient had a revision due to the pectus bar moving.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As these parts were removed in a revision, the complaint is considered confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.For all lorenz pectus support bar 11in (part #01-3711) in the previous one years (from the notification date), there is a complaint rate of 0.06%, which is no greater than the occurrence listed in the application fmea.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 11" PECTUS SUPPORT BAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8593425
• Report Number: 0001032347-2019-00270
• Device Sequence Number: 16646815
• Product Code: HRS
• UDI-Device Identifier: 00841036011017
• UDI-Public: 00841036011017
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 17 YR