MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ PECTUS SUPPORT BAR SYSTEM; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical product - zimmer biomet lorenz pectus support bar system catalog #: pt-3290 lot 937040.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 report: 0001032347-2022-00044.
Event or Problem Description
It was reported that the patient will undergo a revision due to defect recurrence and incorrect bar placement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical product - zimmer biomet lorenz pectus support bar system catalog #: pt-3290 lot 937040.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 report: 0001032347-2022-00044.
Event or Problem Description
It was reported that the patient will undergo a revision due to defect recurrence and incorrect bar placement.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: LORENZ PECTUS SUPPORT BAR SYSTEM
• Common Device Name: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13472439
• Report Number: 0001032347-2022-00045
• Device Sequence Number: 4826645
• Product Code: HRS
• UDI-Device Identifier: 00841036274283
• UDI-Public: (01)00841036274283(10)937050
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K061384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: PT-3291
• Device Lot Number: 937050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown