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	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was 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: 0001032347-2020-00342, 0001032347-2020-00343.Medical products: lorenz pectus support bar system, part# pt-3697, lot# 991830.Lorenz pectus support bar system, part# pt-3698, lot# 991840.
Event or Problem Description
It was reported the custom pectus bars were not an ideal fit during implantation.The surgeon reported the lower bar was too long.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.The device was not returned for investigation because it was implanted without impact to the procedure.No photos, scans, x-rays, or physician's reports were provided.For these reasons, no visual evaluations or functional testing could be conducted.The dhr was reviewed and no non-conformance was found.There are no indications of manufacturing defects.For all patient matched pectus bars (item# pt-xxxx & ps-xxxx) in the previous one year (from the notification date) regarding the bars being too long, there is a complaint rate of(b)(6) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause 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 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: 10362355
• Report Number: 0001032347-2020-00343
• Device Sequence Number: 3066219
• Product Code: HRS
• UDI-Device Identifier: 00888233027694
• UDI-Public: 00888233027694
• 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): 09/29/2020

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-3698
• Device Lot Number: 981840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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
• Patient Age: 18 YR