MAUDE Adverse Event Report: ORTHOFIX SRL TRUE LOK PLUS LONG QUICK ADJUST STRUT

Model Number	50-10190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on (b)(4), batch b1367725 before the market release.No anomalies have been found.The original lot, manufactured in year 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.Orthofix (b)(4) checked the internal records related to the controls made on (b)(4), batch b1484901 before the market release.No anomalies have been found.The original lot, manufactured in year 2020, was comprised of (b)(4) devices.All of them have already been distributed to the market.Orthofix (b)(4) checked the internal records related to the controls made on (b)(4), batch b1512876 before the market release.No anomalies have been found.The original lot, manufactured in year 2020, was comprised of (b)(4) devices.All of them have already been distributed to the market.The technical evaluation on the returned devices, received on february 24, 2021, is currently on going.The information made 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 investigation are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2021-00013 and 9680825-2021-00014.
Event or Problem Description
The information initially provided by local distributor indicates: hospital name: (b)(6).Surgeon name: (b)(6).Date of initial surgery: (b)(6) 2021.Body part to which device was applied: tibia.Surgery description: fracture treatment.Patient's information: (b)(6), male, weight: (b)(6), height: 178cm.Previous health condition: schizophrenia, smoker, ludwig angina.Problem observed during: clinical use on patient and into treatment.Type of problem: device functional problem.Event description: 3 rapid struts have failed on a frame causing an additional fracture.Frame applied to span ankle after plating for pilon fracture.There was no tibial fracture present, the frame was just to protect pilon plating.3 new style struts failed post op, old style strut was fine.Mum says: initially there was 1 strut popping out which happened a few days before incident.Then when he was coming down the stairs all 3 struts popped and he fell down the stairs - this happened sunday (b)(6).Immediately had pain and was unable to weightbear.Mum called the hospital on (b)(6) and decision to see aq in the very next clinic - tuesday (b)(6).Got xrays on tuesday which was when aq raised issue with me.Fracture noted and theatre booked for friday (b)(6)." the complaint report form also indicated: the device failure had adverse effects on patient (see event description) 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: (b)(6) 2021; a medical intervention was required: (b)(6) 2021.Copies of the operative reports are not available.Copies of the x-ray images are not available: patient unable to consent due to mental health difficulties.Patient current health conditions: fractured tibia, put on a new frame today (friday (b)(6)).(b)(4).
Additional Manufacturer Narrative
Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 50-10190 batch b1367725 before the market release.No anomalies have been found.The original lot, manufactured in year 2019, was comprised of 58 devices.All of them have already been distributed to the market.Orthofix srl checked the internal records related to the controls made on the device code 50-10190 batch b1484901 before the market release.No anomalies have been found.The original lot, manufactured in year 2020, was comprised of 49 devices.All of them have already been distributed to the market.Orthofix srl checked the internal records related to the controls made on the device code 50-10190 batch b1512876 before the market release.No anomalies have been found.The original lot, manufactured in year 2020, was comprised of 60 devices.All of them have already been distributed to the market.Technical evaluation: the returned devices, received on 24th february 2021 were examined by orthofix srl quality engineering department.The devices were subjected to visual check as per orthofix srl specification.The visual check evidenced that the true lok plus ball stud of the returned devices is disassembled from the main body.The surface of the sphere is damaged (probably due to the rubbing of the sphere when it goes out of its seat).The test of the axial tension to verify the strength, with which the two components are disassembled, was performed using 50 samples taken from the warehouse.All devices met the design specification: test passed.Medical evaluation: the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed.In this case a 53 year old male patient had sustained a pilon fracture that was repaired with internal fixation.The surgeon applied a truelok frame to neutralise the forces across the fracture and protect the repair.The patient is a chronic schizophrenic, and is unwell enough to be unable to give consent for x-rays to be shared with us.It can be deduced that patient cooperation would not be good because of lack of mental capacity to cooperate.Patient was coming downstairs and 3 of 4 rapid struts separated, so that the patient had immediate pain, was unable to weightbear and fell the rest of the way downstairs.Patient was found to have a new tibial shaft fracture and a new frame has been applied on (b)(6).I agree that this incident must be reported as a serious injury.Final comments: the results of the technical evaluation evidenced that the returned struts were originally conforming to orthofix srl design specifications.During the functional test performed on representative samples from orthofix stock, it was not possible to replicate the problem occurred during clinical use.The struts were received disassembled and not functioning anymore.The signs of damage found on the sphere are of unknown origin.Based on available information it is not possible to determine the root cause of the failure.Orthofix srl continues monitoring the products on the market.Please kindly refer also to mfr report number 9680825-2021-00013 follow up 1 and 9680825-2021-00014 follow up 1.
Event or Problem Description
The information initially provided by local distributor indicates: hospital name: (b)(6) hospital.Surgeon name: (b)(6).Date of initial surgery: (b)(6) 2021.Body part to which device was applied: tibia.Surgery description: fracture treatment.Patient's information: 53 year-old, male, weight: 93kg, height: 178cm.Previous health condition: schizophrenia, smoker, ludwig angina.Problem observed during: clinical use on patient and into treatment.Type of problem: device functional problem.Event description: 3 rapid struts have failed on a frame causing an additional fracture.Frame applied to span ankle after plating for pilon fracture.There was no tibial fracture present, the frame was just to protect pilon plating.3 new style struts failed post op, old style strut was fine.Mum says: initially there was 1 strut popping out which happened a few days before incident.Then when he was coming down the stairs all 3 struts popped and he fell down the stairs- this happened sunday (b)(6).Immediately had pain and was unable to weightbear.Mum called the hospital on monday (b)(6) and decision to see aq in the very next clinic: tuesday (b)(6).Got xrays on tuesday which was when aq raised issue with me.Fracture noted and theatre booked for friday (b)(6)." the complaint report form also indicated: the device failure had adverse effects on patient (see event description).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: (b)(6) 2021.A medical intervention was required: (b)(6) 2021.Copies of the operative reports are not available.Copies of the x-ray images are not available: patient unable to consent due to mental health difficulties.Patient current health conditions: fractured tibia, put on a new frame today (friday (b)(6)).Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

• Brand Name: TRUE LOK PLUS LONG QUICK ADJUST STRUT
• Common Device Name: TRUE LOK PLUS LONG QUICK ADJUST STRUT
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 11397571
• Report Number: 9680825-2021-00015
• Device Sequence Number: 11054331
• Product Code: KTT
• UDI-Device Identifier: 18054242510185
• UDI-Public: (01)18054242510185(11)200714(10)B1512876
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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 Model Number: 50-10190
• Device Catalogue Number: 50-10190
• Device Lot Number: B1512876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 93