MAUDE Adverse Event Report: ORTHOFIX SRL EIGHT-PLATE GUIDED GROWTH PLATE 12MM

Model Number GP200CE

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records.Mfr 9680825-2022-00014.Orthofix srl checked the internal records related to the controls made on the device code gp200ce batch b1275067 before the market release.No anomalies have been found.The original lot, was comprised of 233 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.Mfr 9680825-2022-00015 and 9680825-2022-00016.Orthofix srl checked the internal records related to the controls made on the device code gp400ce batch b1217736 before the market release.No anomalies have been found.The original lot, was comprised of 872 units, manufactured in year 2018.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 devices involved in this event have not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the devices concerned.The technical evaluation will be performed as soon as the devices become available.Medical evaluation: the information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation will be available.As soon as the results of the investigation will be available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information initially provided by local distributor indicates: product code: gp200ce (qty 1) and gp400ce (qty 2) - mfr reports numbers 9680825-2022-00014 and 9680825-2022-00015 and 9680825-2022-00016 respectively - batch number: b1275067 and b1217736.Hospital name: (b)(6).Surgeon name: dr (b)(6).Date of initial surgery: (b)(6) 2021.Body part to which device was applied: both legs.Surgery description: correction.Patient information: 8 years, female, 32kg, 124 cm.Type of problem: clinical (patient) problem.Event description: "intraoperatively, a black color was detected around the blue plate".The complaint report form also indicates: the device failure did not have any 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 not required.A medical intervention was not required.Copies of the operative report are not available.Copies of the x-ray images are not available.Product is available for return.Patient current health condition: patient's health status is good and stable.Further information received on july 26, 2022: the problem was detected during scheduled device removal (explantation performed in march 2022, 6 months from the implantation).Distributor reference number: nc (b)(4).Manufacturer reference number: (b)(4).

Event Description

The information initially provided by local distributor indicates: product code: gp200ce (qty 1) and gp400ce (qty 2) - mfr reports numbers 9680825-2022-00014 and 9680825-2022-00015 and 9680825-2022-00016 respectively.Batch number: b1275067 and b1217736.Hospital name: (b)(6) hospital surgeon name: dr.(b)(6).Date of initial surgery: on (b)(6) 2021.Body part to which device was applied: both legs.Surgery description: correction.Patient information: 8 years, female, 32kg, 124 cm.Type of problem: clinical (patient) problem.Event description: "intraoperatively, a black color was detected around the blue plate".The complaint report form also indicates: the device failure did not have any 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 not required.A medical intervention was not required.Copies of the operative report are not available.Copies of the x-ray images are not available.Product is available for return.Patient current health condition: patient's health status is good and stable.Further information received on july 26, 2022.The problem was detected during scheduled device removal (explantation performed in (b)(6) 2022, 6 months from the implantation).Asymptomatic child.Further information received on august 4th, 2022 there is not any history of metal sensitivity in this patient.There is not any evidence or more details regarding the cleaning fluid which was used to clean these devices.The only evidence supplied by the hospital was the sterilization method: autoclave/steam.Distributor reference number: (b)(4).Manufacturer reference number: (b)(4).

Manufacturer Narrative

Analysis of historical records mfr 9680825-2022-00014.Orthofix srl checked the internal records related to the controls made on the device code gp200ce batch b1275067 before the market release.No anomalies have been found.The original lot, was comprised of (b)(4), 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.Mfr 9680825-2022-00015 and 9680825-2022-00016.Orthofix srl checked the internal records related to the controls made on the device code gp400ce batch b1217736 before the market release.No anomalies have been found.The original lot, was comprised of (b)(4), manufactured in year 2018.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 following devices, received on august 29th, 2022, were examined by orthofix srl quality operations department: one eight-plate guided growth plate 12mm code gp200ce batch b1275067; two eight-plate guided growth plate 16mm code gp400ce batch b1217736; three eight-plate guided growth cannulated screw l.24mm code gp224ce batch b1377430 and one eight-plate guided growth cannulated screw l.32mm code gp432ce batch b1380213 the returned devices were subjected to visual check as per orthofix specification.The visual check of the plates, reference code gp200ce and gp400ce evidenced the following: on the upper side of one plate gp400, in some areas the anodization was removed.The boundaries of these areas do not look sharp, and the titanium anodization is affected by discolouring.This is not detectable on the other plates gp400 and gp200.Spots were detected on all plates and screws, attributable to usage and/or reprocessing.All plates on the back side, showed rounded areas with anodization removed.On the upper side, titanium color is visible with no sharp boundaries.In plate gp200 signs of damage were detected in correspondence to the contact area with the screw.The visual check of the screws, reference code gp224ce and gp432ce evidenced signs of use, attributable to the contact with the respective plates.The devices were then sent to an external laboratory for the failure analysis and the raw material check.The results of the technical analysis detected the following: the raw material analysis confirmed that the items are in conformity with orthofix specifications.Plates show discolouring of the titanium anodization.Around discoloured areas, in correspondence of the dark contour, some small particles and a thin layer of residue has been detected.Eds analysis of such residues showed a composition coherent with bone fragments/saline residues.Screws head show instead a different morphology, coherent with abrasion, with sharp edges.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.It seems in this case that an 8-year-old girl was being treated in both legs with an 8-pate.The plates were implanted on (b)(6) 2021.At re-operation (recent but not specified) it was noted that there was a blue coloration round the plate(s).I would wish to have confirmed if they have been treated with an unusual cleaning agent.I can think of no other particular comment.The patient should have come to no harm as the metal is now removed.Allergy to this titanium alloy is very rare.I have now read this very complete and interesting technical analysis.I note the suggestion that the anodised layer might have been disturbed by the use of plate benders to contour the plate to the bone surface.However, the report cannot suggest a reason why the metallosis happened in just this patient.There may have been particular factors in this application that we will never know.Importantly the report confirms that the material of these plates and screws was to specification, and that they were made from different batches of raw material, excluding the possibility that this might have been a particular batch with strange properties.So, the cause is unknown, although there is to my mind still the possibility of an unusual chemical coming in contact with the plate.Also importantly, the patient has come to no harm.Titanium is an inert metal and should cause no problems if any remains in the patient.Final comments: the results of the technical analysis concluded that the devices' raw material is conforming to orthofix specifications.No defects or inclusions were found.Screws damage is coherent with fretting/abrasion due to motion between plates and screws.The damage on plates is coherent with a cyclical stress applied, which overtime caused small deformations and crazing on the anodization layer, generating the discoloration occurred.In relation to the possible metallosis complained, it is not possible to determine a root cause.No device anomalies were found.Based on the results of the technical evaluation, which confirmed the devices conformity to orthofix specifications, and on the evidence deriving from the medical evaluation, orthofix srl can conclude that the event occurred is not device related.Orthofix srl continues monitoring the devices on the market.

• Brand Name: EIGHT-PLATE GUIDED GROWTH PLATE 12MM
• Type of Device: EIGHT-PLATE GUIDED GROWTH PLATE 12MM
• 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: 15137334
• MDR Text Key: 296951996
• Report Number: 9680825-2022-00014
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 18054242513346
• UDI-Public: (01)18054242513346(11)190129(10)B1275067
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K031493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GP200CE
• Device Catalogue Number: GP200CE
• Device Lot Number: B1275067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 32 KG