MAUDE Adverse Event Report: ORTHOFIX SRL EIGHT PLATE 16MM STERILE

Model Number	99-GP400CE
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code (b)(4), lot b1401154, marked on component (b)(4), before the market release.No anomalies have been found.The original lot, was comprised of (b)(4) units, manufactured in year 2019.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the device involved in this event was received at orthofix srl on may 30, 2022.The technical investigation is in progress.As soon as the results of the investigation are available, orthofix srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.
Event or Problem Description
The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon name: unknown.Date of initial surgery: (b)(6) 2021.Body part to which device was applied: left lateral tibia.Surgery description: fracture treatment.Patient information: (b)(6) year-old.Problem observed during: into treatment.Type of problem: device functional problem.Event description: eight-plate" was placed on the tibia for "left thigh tibial end growth inhibition surgery" and radiographs were taken about eight months later, which revealed a broke in the center of the "eight plate".Extraction surgery was performed to remove the ruptured plate.The date of the damage is unknown, but the damage was discovered on (b)(6) 2022.The complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required: (b)(6) 2022.A medical intervention was required.Copies of the operative report are not available.Copies of the x-ray images are not available so far.Product is available for return.Patient current health condition: unknown.Distributor reference number: (b)(4).Manufacturer reference number: (b)(4).
Event or Problem Description
The information provided by local distributor indicates: - hospital name: (b)(6)rehabilitation center - date of initial surgery: (b)(6) 2021 - body part to which device was applied: left lateral tibia - surgery description: fracture treatment - patient information: 8 years - problem observed during: clinical use on patient/intraoperative - type of problem: device functional problem - event description: eight-plate" was placed on the tibia for "left thigh tibial end growth inhibition surgery" and radiographs were taken about eight months later, which revealed a broke in the center of the "eight plate".Extraction surgery was performed to remove the ruptured plate.- the date of the damage is unknown, but the damage was discovered on (b)(6) 2022.The complaint report form also indicates: - the device failure had adverse effects on patient - the initial surgery was completed with the device - the event did not lead to a delay in the duration of the surgical procedure - an additional surgery was required (done on (b)(6) 2022) - a medical intervention was required (under investigation) - copies of the operative reports are not available - availability of x-rays images are under investigation - product is available for return - the event should be notified to the local competent authority - information about patient current health condition is under investigation.Distributor reference number: (b)(4).Manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
Analysis of historical records.Orthofix srl checked the internal records related to the controls made on the plate code 99-gp400ce batch b1421303 (lot marked on the component is b1401154) before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the returned broken 8plate, received on may 30, 2022, was examined by orthofix srl quality operations department.The broken device was subjected to visual check as per orthofix specification.The visual check confirmed the problem notified: the device is broken.The device was then sent to an external laboratory for the failure analysis and the raw material check.The results of the raw material analysis confirmed that the item is in conformity with orthofix specifications.The results of the technical investigation concluded that the device broke due to fatigue overloading over time.Medical evaluation: the information made available on the case was sent to our medical evaluator.Please find below a summary of the medical evaluation performed."in this case an eight-plate was implanted 8 months previously.The patient has been very active; we have no information about the efficacy of the angular correction achieved.The eight-plate has broken across the middle section with significant deformation of the material.It is not possible to comment on any injury to the patient as we do know anything about the clinical results".Conclusion: the results of the raw material analysis confirmed that the item is in conformity with orthofix specifications.The results of the technical investigation concluded that the device broke due to fatigue overloading over time.The medical evaluation performed evidenced as follows: "in this case an eight-plate was implanted 8 months previously.The patient has been very active; we have no information about the efficacy of the angular correction achieved.The eight-plate has broken across the middle section with significant deformation of the material.It is not possible to comment on any injury to the patient as we do know anything about the clinical results".Based on the results of the technical evaluation, which confirmed the device conformity to orthofix specification, and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem that occurred is not device related.Orthofix srl continues monitoring the devices on the market.

• Brand Name: EIGHT PLATE 16MM STERILE
• Common Device Name: EIGHT PLATE 16MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 14602189
• Report Number: 9680825-2022-00009
• Device Sequence Number: 6168852
• Product Code: HRS
• UDI-Device Identifier: 18033509852657
• UDI-Public: (01)18033509852657(11)191206(17)241106(10)B1421303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2024
• Device Model Number: 99-GP400CE
• Device Catalogue Number: 99-GP400CE
• Device Lot Number: B1421303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Unknown