MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM SHAFER 9 TI PECTUS BAR; PLATE, FIXATION, BONE

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	01/24/2020
Type of Reportable Event	Malfunction
Additional 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: 0001032347-2020-00122, 0001032347-2020-00123.Medical products: pectus system shafer 9 ti pectus bar, part# pt-3452, lot# 964320.Pectus system shafer 9.5 ti pectus bar, part# pt-3453, lot# 964310.
Event or Problem Description
It was reported the surgeon preferred the custom pectus bar to be shorter.The custom pectus bars were successfully implanted.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 cannot be verified.Functional testing and inspections could not be performed due to the product not being returned and no photographs being provided.The dhr was reviewed there were no non-conformances found.There are no indications of manufacturing defects.Due to these products being custom fit a review was conducted on all part numbers pt-xxxx for the last year regarding the bar not fitting; (b)(4).The most likely underlying cause cannot 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS SYSTEM SHAFER 9 TI PECTUS BAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9730201
• Report Number: 0001032347-2020-00122
• Device Sequence Number: 19421245
• Product Code: HRS
• UDI-Device Identifier: 00841036279905
• UDI-Public: 00841036279905
• 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): 07/22/2020

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-3452
• Device Lot Number: 964320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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: 11 YR