MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM CHANEY 13 TI PECTUS BAR; CUSTOM PECTUS BAR

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis; 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: 0001032347-2019-00587, 0001032347-2019-00588, medical products: pectus system chaney 13 ti pectus bar, part# pt-3339, lot# 953070 pectus system chaney 13 ti pectus bar, part# pt-3340, lot# 953080 pectus system chaney 13 ti pectus bar, part# pt-3341, lot# 953090.
Event or Problem Description
It was reported the surgeon could not optimally position stabilizers on a pectus bar.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 products remaining implanted.The dhr was reviewed for pt-3341 and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint in regards to the bar not being able to positioned easily for pt-3341 lot 953090.Due to low sales of these parts (pt-3339, pt-3340, pt-3341) a one-year complaint review was conducted on the part family (pt-xxxx) and in the previous one year (from the notification date).Regarding fit issues, there is a complaint rate of 0.16%, which is no greater than the occurrence listed in the application fmea.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 CHANEY 13 TI PECTUS BAR
• Common Device Name: CUSTOM PECTUS BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9532421
• Report Number: 0001032347-2019-00589
• Device Sequence Number: 16739931
• Product Code: HRS
• UDI-Device Identifier: 00841036277185
• UDI-Public: 00841036277185
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PT-3341
• Device Lot Number: 953090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 05/19/2020
• 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