MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM SMOOTH PECTUS BAR 25.4CM (10IN)(L); PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint cmp (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: 0001032347-2020-00471, 0001032347-2020-00473.Medical products: pectus system smooth pectus bar 25.4cm (10in)(l), part# 01-3710-p, lot# 787280, pectus system smooth pectus bar 25.4cm (10in)(l), part# 01-3710-p, lot# j3839223, pectus system smooth pectus bar 27.9cm (11in)(l), part# 01-3711-p, lot# j3805905.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported the patient has been hospitalized for a recurrent pneumothorax fifty-six days following implantation of four (4) pectus support bars.The patient underwent a revision to address device migration fourteen (14) days following implantation of pectus support bars.The patient has previously undergone two (2) emergency surgeries to address the development of a pneumothorax.The patient remains hospitalized for the recurrent pneumothorax.It was reported that no further information is available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined the initial report was forwarded in error and should be voided.This report was found to be a duplicate/continuation of the event in report: 0001032347-2020-00479.

• Brand Name: PECTUS SYSTEM SMOOTH PECTUS BAR 25.4CM (10IN)(L)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10593152
• Report Number: 0001032347-2020-00472
• Device Sequence Number: 14443217
• Product Code: HRS
• UDI-Device Identifier: 00841036076221
• UDI-Public: 00841036076221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 01-3710-P
• Device Lot Number: J3839223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 04/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 15 YR