MAUDE Adverse Event Report: ORTHOFIX SRL 180 MM DOUBLE ROW FOOT PLATE

Model Number 1

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  Injury  

Event Description

The information initially provided by local distributor indicates: date of initial surgery: unidentified.Body part to which device was applied: tibia and foot.Surgery description: fracture treatment.Patient's information: female.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: "patient came to clinic with a broken 3/8 hex ring, at the point next to the joint.Patient has been doing 15,000 steps a day so surgeon thinks this is what it could be down to.Same patient came to clinic with broken footplate.Footplate was removed and patient happy." the complaint report form also indicated: the device failure had no 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: not sure but probably the same week to put on new ring (after 3/8 broke).A medical intervention (outpatient clinic) was not required: just routine clinic visits.Copy of operative reports is not available.Copy of x-ray images is available.Patient's current health condition: fine, should have frame removed soon.Further information received from the local distributor on 17 january 2022: a revision surgery with anaesthesia was necessary after 29/11 in order to replace the broken 3/8 ring with a new 3/8 ring.The broken footplate was taken off in clinic without anesthesia and it was not replaced the treatment is successfully on-going.(b)(4).Please also kindly refer to mfr report 9680825-2022-00001.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code (b)(4), lot b1630544 before the market release.No anomalies have been found.The original lot, manufactured in 2021 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.Orthofix srl checked the internal records related to the controls made on the device code (b)(4), lot 1902741 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 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.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.Please kindly refer also to mfr report 9680825-2022-00001.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 56-23080 lot b1630544 before the market release.No anomalies have been found.The original lot, manufactured in 2021 was comprised of (b)(4).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.Orthofix srl checked the internal records related to the controls made on the device code 56-13655 lot 1902741 before the market release.No anomalies have been found.The original lot, manufactured in 2019 was comprised of (b)(4).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 rings, received on 24th february 2022, were examined by orthofix srl quality engineering department.The devices were subjected to visual and dimensional check as per orthofix srl design and product specification.The visual check evidenced that both rings are broken, with signs of damage and use.The dimensional check did not evidence any anomalies.It was not possible to perform the functional check as the devices are broken.Samples of the involved devices were sent to an external laboratory for further investigation and failure analysis.The analysis performed evidenced that the involved samples show a very clean and brittle fracture surface.No defect, inclusion or corrosion residue have been found.-code 56-13655: it is characterized by the presence of a moderate fatigue propagation area which led to the final brittle fracture once the resistant section was sufficiently depleted by the crack advance.The failure is coherent with a cyclic flexural overload applied on the component, which triggered and propagated cracks in correspondence of holes.-code 56-23080: fracture surfaces are both extremely clean and brittle.No fatigue propagation area was found and the microscopic morphology is mainly coherent with a brittle cleavage, due to a very impulsive and strong overload.Material chemical composition, hardness and microstructure are coherent with the expected aluminum alloy en aw-7075.Final comments: the results of the technical evaluation evidenced that the returned rings were originally conforming to design specifications.From the evidences collected, it can be concluded that the failure was mainly caused by devices mechanical overload, due to asymmetrical tensioning of the system and asymmetrical threaded bars positioning.From the pictures provided, it possible to see that three bars (in blue) are connected to the 5/8 ring (1-2-4), while 1 bar is connected to the 3/8 ring.Bars identified in orange are dislocated differently: 2 on the 3/8 ring and 2 on the 5/8 ring.This creates some unbalancing, giving excessive rigidity to the posterior side, while the anterior part is not adequately supported and acts as a cantilever.This could have impacted on system balance, causing overload on rings in that specific area.The breakages occurred could be mainly related to the loads to which the device was subjected during treatment.Orthofix srl continues monitoring the devices on the market.Please kindly refer also to mfr report 9680825-2022-00001 follow up 1.

Event Description

The information initially provided by local distributor indicates: - date of initial surgery: unidentified.- body part to which device was applied: tibia and foot.- surgery description: fracture treatment.- patient's information: female.- problem observed during: into treatment/post-operative.- type of problem: device functional problem.- event description: "(b)(6) - patient came to clinic with a broken 3/8 hex ring, at the point next to the joint.Patient has been doing 15,000 steps a day so surgeon thinks this is what it could be down to.(b)(6) - same patient came to clinic with broken footplate.Footplate was removed and patient happy." the complaint report form also indicated: - the device failure had no 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: not sure but probably the same week to put on new ring (after 3/8 broke).- a medical intervention (outpatient clinic) was not required: just routine clinic visits.- copy of operative reports is not available.- copy of x-ray images is available.- patient's current health condition: fine, should have frame removed soon.Further information received from the local distributor on 17 january 2022: -a revision surgery with anaesthesia was necessary after (b)(6) in order to replace the broken 3/8 ring with a new 3/8 ring -the broken footplate was taken off in clinic without anesthesia and it was not replaced -the treatment is successfully on-going manufacturer ref: (b)(4).Distributor ref: (b)(4).Please also kindly refer to mfr report 9680825-2022-00001 follow up 1.

• Brand Name: 180 MM DOUBLE ROW FOOT PLATE
• Type of Device: 180 MM DOUBLE ROW FOOT PLATE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 13341736
• MDR Text Key: 289191179
• Report Number: 9680825-2022-00002
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 18033509858178
• UDI-Public: (01)18033509858178(11)190529(10)1902741
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K941048
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1
• Device Catalogue Number: 56-13655
• Device Lot Number: 1902741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female