| Model Number 99-612660 |
| Device Problem
Mechanical Problem (1384)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 10/07/2016 |
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Event Type
malfunction
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Manufacturer Narrative
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Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the ring code 56-21440 lot v1414128 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint notified from this specific device lot (please kindly refer to mfr report 9680825-2016-00094).Orthofix (b)(4) checked the internal records related to the controls made on the bone screw code 99-612660 lot g017 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint notified from this specific device lot (please kindly refer to mfr report 9680825-2016-00095).Technical evaluation: the technical evaluation of the devices involved, received on october 13, 2016, is currently on going.Medical evaluation: the information 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 will be available.Orthofix (b)(4) has requested further information on the event, such as information about the timescale of the treatment or the geometry of the frame, how the bone screws were configured, date of initial surgery, date of frame removal, copied of the x-ray images.Unfortunately this information has not yet been made available.As soon as the results of the investigation will be available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2016-00094.Device under technical evaluation.
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Event Description
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The information provided by the local distributor indicates: devices code: 56-21440 (please refer to mfr report 9680825-2016-00094) and 99-612660 (please refer to mfr report 9680825-2016-00095); lot numbers: v1414128 (ring) and g017 (bone screw); quantity: 2; hospital name: (b)(6) hospital; surgeon name: mr (b)(6); date of initial surgery: tbc; body part to which device was applied: tibia; surgery description: fracture treatment; patient's information: male, middle age; problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: during a removal of a frame of tl hex at southampton today a fatigued ring was discovered (b)(6) 2016 (between a 5/8 and 3/8 joining).It was then apparent that the half pin had fatigued in the patient, this was believed to be secondary, as the x-ray taken previously taken to the removal didn't show the half pin to be broken.The complaint report form also indicates: the device failure did not have any adverse effects on patient; the surgery was completed with used device; the event led to a clinically relevant increase in the duration of the surgical procedure (extra anesthesia 40 minutes); an additional surgery was not required; copies of the operative report are not available; copies of the x-ray images are not available; information on patient current health condition: not provided note and comments: removed half pin with bone graft set and used cerement g to fill the hole.Please also kindly refer to mfr report 9680825-2016-00094.(b)(4).
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Manufacturer Narrative
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Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the ring code 56-21440 lot v1414128 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint notified from this specific device lot (please kindly refer to mfr report 9680825-2016-00094).Orthofix (b)(4) checked the internal records related to the controls made on the bone screw code 99-612660 lot g017 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint notified from this specific device lot (please kindly refer to mfr report 9680825-2016-00095).Technical evaluation (please also kindly refer to mfr report 9680825-2016-00094).The returned devices, received on october 13th, 2016, were examined by orthofix (b)(4) quality engineering area.The devices were subjected to visual and dimensional check as per orthofix (b)(4) specification.The visual check evidenced that the 5/8 ring is broken in correspondence to the coupling with the 3/8 ring.The visual check of the bone screw confirmed that is broken in its threaded part.The dimensional check of the returned devices, performed where possible, did not evidence any anomalies.The devices were 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 devices conformity to design specification.Both devices were subjected to cyclic loading and broke due to fatigue.Medical evaluation (please also kindly refer to mfr report 9680825-2016-00094).The information made available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed."in this case the treatment had finished and the frame was being removed.It was discovered that the junction piece of a 5/8 ring had developed a crack but was not displaced.The adjacent 3/8 ring section seems undamaged.Also one ha coated bone screw was discovered to be broken.From what we are told the treatment was not affected.The surgeon had to remove the bone screw fragment, and the hole left by this was filled with synthetic bone graft.However, we have no information about the timescale of the treatment or the geometry of the frame.Fatigue failure of a 6 mm bone screw is rare and is caused by cyclic loading beyond its design criteria.The use of tensioned wires and screws to provide bone fixation will tend to focus cyclic loading on to the bone screw because it is more rigid.We understand from the tm that the frame consisted of 5 bone screws and 2 tensioned wires.A middle aged male patient would normally require 3 bone screws on each side of the fixation.We need to know how the bone screws were configured.It looks from the diagram that the 2 distal bone screws were close together on one side of the distal ring, on a 2 hole and 4 hole post respectively.If the distal fixation consisted of one screw on a 4 hole post, one screw on a 2 hole post and 2 tensioned wires, then each component of the distal fixation would have a different stiffness, and loading the frame would tend to load the stiffest component first.It also seems that the 2 distal screws were each side of the ring joint that developed fatigue failure, and this might have happened because of the differential stiffness.Some of this is hypothesis based on incomplete information.If we had more details of the exact location of the fixation elements and a more complete timescale we could be more sure why these breakages occurred.I fully expect that they did occur because of the particular physical characteristics of this frame"."the technical analysis report shows clearly that the ring tab and the bone screw both failed because of fatigue.We do not have complete information on the frame configuration, but the diagram sent with the complaint form shows that the fixation was localised on the 5/8 ring close to the fixation tab with the 3/8 ring.It should be noted that the failures were noted at the time of fixation removal.This suggests that full healing of whatever correction was being made was complete.When the healing has occurred, the bone will be loaded more because of a lack of pain.This will result in significantly greater bending forces being transmitted to the frame, which then failed at the weak point.Even greater load was then transferred to the bone screw which also failed.These failures would not have happened if the frame had been removed earlier"."these failures happened because of specific aspects of the frame design".Final comments (please also kindly refer to mfr report 9680825-2016-00094) from the results of the technical evaluation, it was confirmed the devices conformity to design specification.Both devices were subjected to cyclic loading and broke due to fatigue.The medical evaluation evidenced as follow: "in this case the treatment had finished and the frame was being removed.It was discovered that the junction piece of a 5/8 ring had developed a crack but was not displaced.The adjacent 3/8 ring section seems undamaged.Also one ha coated bone screw was discovered to be broken.From what we are told the treatment was not affected.The surgeon had to remove the bone screw fragment, and the hole left by this was filled with synthetic bone graft.However, we have no information about the timescale of the treatment or the geometry of the frame.Fatigue failure of a 6 mm bone screw is rare and is caused by cyclic loading beyond its design criteria.The use of tensioned wires and screws to provide bone fixation will tend to focus cyclic loading on to the bone screw because it is more rigid.We understand from the tm that the frame consisted of 5 bone screws and 2 tensioned wires.A middle aged male patient would normally require 3 bone screws on each side of the fixation.We need to know how the bone screws were configured.It looks from the diagram that the 2 distal bone screws were close together on one side of the distal ring, on a 2 hole and 4 hole post respectively.If the distal fixation consisted of one screw on a 4 hole post, one screw on a 2 hole post and 2 tensioned wires, then each component of the distal fixation would have a different stiffness, and loading the frame would tend to load the stiffest component first.It also seems that the 2 distal screws were each side of the ring joint that developed fatigue failure, and this might have happened because of the differential stiffness.Some of this is hypothesis based on incomplete information.If we had more details of the exact location of the fixation elements and a more complete timescale we could be more sure why these breakages occurred.I fully expect that they did occur because of the particular physical characteristics of this frame"."the technical analysis report shows clearly that the ring tab and the bone screw both failed because of fatigue.We do not have complete information on the frame configuration, but the diagram sent with the complaint form shows that the fixation was localised on the 5/8 ring close to the fixation tab with the 3/8 ring.It should be noted that the failures were noted at the time of fixation removal.This suggests that full healing of whatever correction was being made was complete.When the healing has occurred, the bone will be loaded more because of a lack of pain.This will result in significantly greater bending forces being transmitted to the frame, which then failed at the weak point.Even greater load was then transferred to the bone screw which also failed.These failures would not have happened if the frame had been removed earlier"."these failures happened because of specific aspects of the frame design".A complete medical evaluation of the case was not performed as some information about the medical procedure was not made available, i.E.Copies of the x-ray images, copies of the operative report and timescale of the treatment.Based on the results of the technical investigation and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is mainly due to the mechanical characteristic of the frame's architecture.Orthofix (b)(4) historical records shows that no other notifications have been received in regards to these specific device lots.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr report 9680825-2016-00094.
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Event Description
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The information provided by the local distributor indicates: devices code: 56-21440 (please refer to mfr report 9680825-2016-00094) and 99-612660 (please refer mfr report 9680825-2016-00095); lot numbers: v1414128 (ring) and g017 (bone screw); quantity: 2; hospital name: (b)(6) hospital; surgeon name: mr (b)(6); date of initial surgery: tbc; body part to which device was applied: tibia; surgery description: fracture treatment; patient's information: male, middle age; problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: during a removal of a frame of tl hex at southampton today a fatigued ring was discovered - (b)(6) 2016 (between a 5/8 and 3/8 joining).It was then apparent that the half pin had fatigued in the patient, this was believed to be secondary, as the x-ray taken previously taken to the removal didn't show the half pin to be broken.The complaint report form also indicates: - the device failure did not have any adverse effects on patient; - the surgery was completed with used device; - the event led to a clinically relevant increase in the duration of the surgical procedure (extra anesthesia 40 minutes); - an additional surgery was not required; - copies of the operative report are not available; - copies of the x-ray images are not available; - information on patient current health condition: not provided - note and comments: removed half pin with bone graft set and used cerement g to fill the hole on (b)(6) 2016, orthofix (b)(4) received the following additional information from the local distributor: - information about the timescale of the treatment or the geometry of the frame: "an exact timescale not available, but hospital provided two dates, either ring was applied on patient on (b)(6) 2015, but it is fatigued was discovered only on (b)(6) 2016".- we need to know how the bone screws were configured: "tm has highlighted the pin position in the image attached".- date of initial surgery: "we are not sure of an exact date it could be either (b)(6) 2014 or (b)(6) 2015".- date of frame removal: "a fatigued ring was discovered - (b)(6) 2016 (between a 5/8 and 3/8 joining)".- copies of the x-rays images: "not available".Please also kindly refer to mfr report 9680825-2016-00094.(b)(4).
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