MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ PECTUS SUPPORT BAR SYSTEM; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was successfully 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: 0001032347-2020-00308, 0001032347-2020-00375, 0001032347-2020-00376.Medical products: lorenz pectus support bar system, part# pt-3652, lot# 989080.Lorenz pectus support bar system, part# pt-3653, lot# 989070.Lorenz pectus support bar system, part# pt-3654, lot# 989060.
Event or Problem Description
It was reported that custom pectus bars were not an ideal fit.The surgeon reported the bars were too long.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was not returned for investigation as it was implanted.The complaint was confirmed by a review of intraoperative photos.The surgeon stated the ends were flared out too far and they had to be bent to make the bar sit flush.Per the ifu, "the degree of initial reshaping and permanent remodeling for each case cannot be predetermined." the manufacturing history was reviewed and no discrepancies related to the reported event were found.A complaint history review was conducted and this was the only complaint (3 parts total) of the bars not being contoured correctly.This leads to a complaint rate of 0.24%, which is no greater than the occurrence listed in the application fmea.Root cause was unable to be determined.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.The following fields were updated: date of this report.Describe event or problem.Date received by manufacturer.If follow-up, what type.Device evaluated by manufacturer.Not returned to manufacturer.Method.Results.Conclusions.Additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: LORENZ PECTUS SUPPORT BAR SYSTEM
• Common Device Name: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10397277
• Report Number: 0001032347-2020-00375
• Device Sequence Number: 19460040
• Product Code: HRS
• UDI-Device Identifier: 00888233026871
• UDI-Public: 00888233026871
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PT-3653
• Device Lot Number: 989070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 08/22/2020
• 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
• Patient Age: 17 YR