MAUDE Adverse Event Report: ORTHOFIX SRL TL PLUS HALF RING 120MM

Model Number 56-11590

Device Problem Break (1069)

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

Event Type  Injury  

Event Description

The information provided by local distributor indicates: hospital name: (b)(6).Surgeon's name: (b)(6).Date of initial surgery: (b)(6) 2022.Body part to which device was applied: foot.Surgery description: correction.Patient's information: 8 year-old, female, previous health condition: none.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: the frame of the patient was a ring foot and a full ring on the tibia.The half ring, on the foot plate ring, broke during the correction.The surgeon asked the patient not to move her foot too much, before taking the frame off.The complaint report form also indicated: an additional surgery was not required, a medical intervention (outpatient clinic) was not required, the problem occurred during the first use of the device, patient's current health condition: good.Further information received on (b)(6) 2023: the device broke in (b)(6) 2023.Circumstances of the failure (what was doing the patient at the moment of the failure?): unknown.The patient is pretty young.The full frame has been removed because the consolidation part was almost finished.There were no adverse effects on patient.The treatment ended successfully, but patient and parents were very scared.X-ray images available are not available.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

Manufacturer Narrative

Analysis of historical records: (b)(4).Technical evaluation: the device involved in this event has not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the device concerned.The technical evaluation will be performed as soon as the device becomes 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.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code: 56-11590, batch: 1911889 marked on the component, before the market release.No anomalies have been found.The original lot, was comprised of (b)(4) units, used to manufacture different finished lots between years 2020-2021.All of them have already been distributed to the market.According to orthofix srl historical records, no other similar notifications have been received for this specific device lot.Technical evaluation: the returned device, received on 23rd june 2023, was examined by orthofix srl quality engineering department.The device was subject to visual and dimensional check as per orthofix srl design and product specification.The visual check evidenced that the half ring is broken at one end.The marks identified on ring extremity are likely related to bolt tightening.Marks show that the bolt was tightened not completely aligned with the respective ring's hole.The involved device was then sent to an external laboratory for further investigation and failure analysis.The analysis performed evidenced the presence of worn and oxidized material on one side.The marking left from the tightening of the screws is not concentric with the hole and in the breakage area the contact between the screw head and the component is minimal, thus suggesting a strong stress concentration effect.The presence of a fracture plane in correspondence of this area and with a 45° inclination in respect to the surface, suggests the formation of an excessive stress on the hole corner which could have led to the formation of the initial crack, possibly during the screw tightening or during a solicitation event occurred during the component work life.Material composition, structure and hardness are coherent with the prescribed material.The dimensional check did not evidence any anomalies.It was not possible to perform the functional check as the device is broken.Medical evaluation: the information made available on the event, with the outcome of the technical evaluation, was sent to our medical consultant.Please find below an extract of the medical evaluations performed.This patient is an 8-year-old girl who is having treatment to a foot; the fixator was applied on (b)(6) 2022.Patient's weight is not specified.Shortly before the end of treatment the patient and parents noticed a crack in the 120 mm half ring.It did not affect the treatment which was needed only for a bit longer ("a few days") before it was removed.The surgeon secured the ring for the last period of treatment.The end result was not affected, and treatment finished as planned.I expect that this ring sustained fatigue failure because of an active patient.The technical analysis confirms that the end of the half ring broke off because of fatigue failure.It also shows that the fatigue failure was almost certainly initiated because of slight misalignment of the half ring with the foot plate, which was probably caused by slight deformation of the foot plate after application to the patient.The result was that the fixing bolt was slightly angled, which resulted in uneven loading of the joining surfaces, and a small amount of damage to the end of the half ring which would have acted as a focus for the subsequent fatigue fracture.I agree with the conclusions of the technical analysis.Final comments: the marks present close to the breakage are due to the strong tightening of the bolt, not completely aligned with the hole.This caused stress concentration and the subsequent crack formation at the contact area.This crack triggered the propagation of fatigue driven phenomenon, causing an increasing allowance between the coupled components.When the fracture phenomenon reached a tipping point, the component yielded on both sides of the hole.Material composition, structure and hardness are coherent with the prescription.No defects were detected.From the evidence collected, it can be concluded that the issue notified is related to a fatigue fracture.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by local distributor indicates: hospital name: (b)(6).Date of initial surgery: on (b)(6) 2022.Body part to which device was applied: foot.Surgery description: correction.Patient's information: 8 year-old, female, previous health condition: none.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: the frame of the patient was a ring foot and a full ring on the tibia.The half ring, on the foot plate ring, broke during the correction.The surgeon asked the patient not to move her foot too much, before taking the frame off.The complaint report form also indicated: an additional surgery was not required.A medical intervention (outpatient clinic) was not required.The problem occurred during the first use of the device.Patient's current health condition: good.Further information received on 13 june 2023.The device broke on (b)(6) 2023.Circumstances of the failure (what was doing the patient at the moment of the failure?) unknown.The patient is pretty young.The full frame has been removed because the consolidation part was almost finished there were no adverse effects on patient.The treatment ended successfully, but patient and parents were very scared.X-ray images available are not available.Manufacturer reference number: 2023104.Distributor reference number: 91.

• Brand Name: TL PLUS HALF RING 120MM
• Type of Device: TL PLUS HALF RING 120MM
• 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 37012 ; IT 37012
• MDR Report Key: 17168984
• MDR Text Key: 317535995
• Report Number: 9680825-2023-00024
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 56-11590
• Device Catalogue Number: 56-11590
• Device Lot Number: 1911889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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