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

Model Number	1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
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 b1484901 before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of (b)(4) devices.All of them have already been distributed to the market.Technical evaluation: the technical evaluation on the returned devices, received on march 9, 2021, is currently on going.Medical evaluation: 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 srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2021-00019.
Event or Problem Description
The information provided by local distributor indicates: hospital name: (b)(6).Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2021.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient's information: (b)(6) year-old, male, previous health condition: good.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: "two struts broke during surgery at head level." the complaint report form also indicated: the device failure had adverse effects on patient: instability of the fixator.The initial surgery was not completed with the device.A replacement device was not immediately available to complete surgery: i had to command two others struts and apply them on patient one day after the surgery.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 reports are not available.Copies of the x-ray images are available.Patient current health conditions: no effect to patient health.Further information received on february 17, 2021 from the local distributor: struts have been replaced this morning without anesthesia.No problem.(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 b1484901 before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of (b)(4) devices.All of them have already been distributed to the market.Technical evaluation: the returned devices, received on march 9, 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 (b)(4) 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 result of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.This is a 61 year old male patient with a total knee replacement.He has sustained a distal femoral fracture above the prosthesis, going down to a condyle.He has been treated with a truelok frame across the knee, using 4 tl-hex rings in 2 pairs.I suspect that this is a temporary fixation prior to definitive surgery.The head ends of 2 of the struts broke during application.They clearly had not replacements and ordered some more, replacing them without anaesthetic on the following day.The fixation of the ring pairs was with bone screws, and would have been simple enough to replace 2 struts with the patient laying flat on a bed.So we can confidently say that the patient came to no harm.However, medical intervention was required to prevent more problems, and i agree that this must be considered 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 devices on the market.Please kindly refer also to mfr report number 9680825-2021-00019 follow up 1.
Event or Problem Description
The information provided by local distributor indicates: hospital name: (b)(6).Surgeon name: dr (b)(6).Date of initial surgery: (b)(6) 2021.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient's information: 61 year-old, male, previous health condition: good.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: "two struts broke during surgery at head level.".The complaint report form also indicated: the device failure had adverse effects on patient: instability of the fixator.The initial surgery was not completed with the device.A replacement device was not immediately available to complete surgery: i had to command two others struts and apply them on patient one day after the surgery 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 reports are not available.Copies of the x-ray images are available.Patient current health conditions: no effect to patient health.Further information received on february 17, 2021 from the local distributor: struts have been replaced this morning without anesthesia.No problem.Manufacturer ref: (b)(4).Distributor ref: (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: 11468946
• Report Number: 9680825-2021-00018
• Device Sequence Number: 14463409
• Product Code: KTT
• UDI-Device Identifier: 18054242510185
• UDI-Public: (01)18054242510185(11)200527(10)B1484901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/13/2021

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: 1
• Device Catalogue Number: 50-10190
• Device Lot Number: B1484901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR