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	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (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: 0001032347-2020-00460, 0001032347-2020-00462.Concomitant 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 underwent a revision to adjust the position of pectus support bars one (1) month following implantation due to device migration.No additional patient consequences have been reported.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.The supplier dhr for the pectus bar was not requested.The parts passed all inspection criteria and sub-criteria.A definitive root cause cannot be determined.If any further information 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
No further event information available at the time of this report.

• 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: 10587390
• Report Number: 0001032347-2020-00461
• Device Sequence Number: 11520323
• 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): 05/25/2021

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?: Yes
• 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: 05/24/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 05/26/2021
• 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