MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 13" PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
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.It is unknown at this time if the device will be returned for evaluation.Attempts have been made but no further information is available at this time.
Event or Problem Description
It was reported that a patient was presenting with metal allergies following the implantation of a pectus bar.Attempts have been made but no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint was opened because a metal allergy on behalf of the surgeon.The lorenz pectus support bar 13in (part# 01-3713, lot# unk) was not returned for investigation.Physician confirmed a metal patch test was done and came back negative.The patient's rash was resolved with prescribed oral and topical medication and has not recurred since; therefore the complaint is unconfirmed and the most likely underlying cause could not be determined.There are no indications of manufacturing defects.For this part (01-3713) and the previous one year (from the notification date), there was a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.There is no indication of manufacturing defects and there are no updates to the risk documents needed.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 13" PECTUS SUPPORT BAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9175319
• Report Number: 0001032347-2019-00439
• Device Sequence Number: 11456746
• Product Code: HRS
• UDI-Device Identifier: 00841036011031
• UDI-Public: 00841036011031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3713
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention