MAUDE Adverse Event Report: ORTHOFIX SRL XCALIBER BONE SCREW STERILE L260/30MM THREAD D6.0-5.6MM

Model Number 99-912630

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 03/03/2023

Event Type  malfunction  

Event Description

The information initially provided by local distributor indicates: product code: 99-912630.Hospital name: (b)(6) children's health and medical center.Date of initial surgery:(b)(6) 2022.Body part to which device was applied: femur.Surgery description: correction.Patient information: 14 years, male.Problem observed during: into treatment/post-operative.Event description: "a 14-year-old male patient was fitted with an lrs lengthening device for femoral lengthening, extending the femur by approximately 1 mm per day.(started early october 2022.) on march 3, 2023, during bone lengthening, the screw broke and was left behind in the patient's body.The screw that was left in the patient's body was subsequently retrieved.(the screw was disposed of in the hospital.)" 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.Copies of the operative reports are not available.Copies of the x-ray images are not available.Product is available for return.Patient current health condition: there is no problem with the patient's condition.On march 29, 2023, orthofix srl received the following additional information from the local distributor: - date of the additional surgery: (b)(6) 2023.- code of the fixator used with the bone screw: (b)(6).Manufacturer ref: 2023057.Distributor ref: 2022-1975.

Manufacturer Narrative

Analysis of historical records: the device involved in this event has not yet been received by orthofix srl.Unfortunately also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.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.Orthofix srl has requested further information on the event such as device batch number, patient weight, patient diagnosis, total lengthening planned, lengthening achieved before device failure, picture of the frame application, copy of the pre and post-operative x-rays, information about completion of the treatment.Unfortunately, this information was not made 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.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the component code 912630 batch 28835844 before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of (b)(4) units, assembled in several batches of finished code 99-912630.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received from this specific device lot.Technical evaluation: the portion of the returned broken screw, received on april 6, 2023, was examined by orthofix quality operations department.The returned portion of the bone screw was subjected to visual check as per orthofix specification.The visual check confirmed the problem notified, the screw is broken in correspondence of the threaded portion.It was also evidenced that the screw stem is slightly bent along its axis, indicating that the screw was overloaded.A functional check on the returned screw was not possible as the device is broken and therefore not functioning.The device was then sent to an external laboratory for the raw material check and the failure analysis.From the results of the technical evaluation, it was confirmed the device conformity to design specification.The screw broke due to fatigue failure most likely related to an excessive cyclic load applied.Medical evaluation: a medical evaluation of the case was not performed as no information about the medical procedure, diagnosis and x-ray images have been made available.Conclusion: from the results of the technical evaluation, it was confirmed the device conformity to design specification.The screw broke due to fatigue failure most likely related to an excessive cyclic load applied.A medical evaluation of the case was not possible as no information about the medical procedure, diagnosis and x-ray images have been made available.Orthofix requested further information on the event such as: patient weight and diagnosis, lengthening planned and lengthening achieved before the screw failure, information about the completion of the treatment, picture of the application and copies of the x-ray images.Unfortunately, no other details were made available.As no information have been provided by the hospital on the specific application, it is not possible to conduct a root cause analysis.Based on the results of the technical evaluation, orthofix can conclude that the breakage that occurred is not device related.Orthofix historical records shows that no other notifications have been received from this specific device code.Should additional information become available, orthofix will finalize the investigation.Orthofix srl continues monitoring the devices on the market.

Event Description

The information initially provided by local distributor indicates: product code: 99-912630.Hospital name: (b)(6).Date of initial surgery: (b)(6) 2022.Body part to which device was applied: femur.Surgery description: correction.Patient information: 14 years, male.Problem observed during: into treatment/post-operative.Event description: "a 14-year-old male patient was fitted with an lrs lengthening device for femoral lengthening, extending the femur by approximately 1 mm per day.(started (b)(6) 2022.) on (b)(6) 2023, during bone lengthening, the screw broke and was left behind in the patient's body.The screw that was left in the patient's body was subsequently retrieved.(the screw was disposed of in the hospital.)" 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.Copies of the operative reports are not available.Copies of the x-ray images are not available.Product is available for return.Patient current health condition: there is no problem with the patient's condition.On march 29, 2023, orthofix srl received the following additional information from the local distributor: date of the additional surgery: (b)(6) 2023.Code of the fixator used with the bone screw: 53500.No other information was given.Manufacturer ref: (b)(4).Distributor ref: (b)(4).

• Brand Name: XCALIBER BONE SCREW STERILE L260/30MM THREAD D6.0-5.6MM
• Type of Device: XCALIBER BONE SCREW STERILE L260/30MM THREAD D6.0-5.6MM
• 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, 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 16689164
• MDR Text Key: 312977333
• Report Number: 9680825-2023-00014
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955848
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99-912630
• Device Catalogue Number: 99-912630
• Device Lot Number: UNKNOWN (LOT MARKED 28835844)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Male