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Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 50009, lot e85 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) units.(b)(4) of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation the device involved, received on (b)(6) 2016 is currently under technical evaluation.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 technical evaluation will be available.As soon as further information is available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).Device under technical evaluation.
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The information provided by the local distributor indicates: product code: 50009; batch number: e85; quantity: 1; hospital name: (b)(6) hospital; surgeon name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: left femur; surgery description: lengthening, correction; patient information: (b)(6) years, male; problem observed during: into treatment/post-operative; type of problem: device functional problem.Event description: the surgeon attached a fixator (lrs adv) to a patient for the lengthening and the correction of the femur.After one week of the operation, s/he started the lengthening of the fixator for a patient.The details of the lengthening were as follows.The lengthening was 1mm a day.(a quarter lap per once) (four times a day) the patient seemed to need considerable power for the turn of the cd unit from a start of the lengthening.After approximately three weeks, when a patient turned cd unit, a creak seemed to come to occur from cd unit.The cd unit was finally broken.The loss of the correction seemed to occur to a patient.The replacement to the cd unit ((b)(4)) and re-lengthening seemed to be carried out for a patient.The surgeon asked (b)(6) for an investigation about the cause that the cd unit was broken.(b)(6) confirmed the returned product was broken.Furthermore, we found the deformation of the pin.I will share it with you for your reference.Please kindly find some photos.Please investigate this if it has some issue.(additional information) the cd unit seemed to be connected to the outrigger of the micrometric swivelling clamp.The device failure had adverse effects on patient (loss of distraction/correction achieved).The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.A medical intervention was required (performed in (b)(6) 2016).Copies of the operative report are not available.Copies of the x-ray images are available.Patient current health condition: under treatment.(b)(4).
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Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 50009 lot e85 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) units.(b)(4) of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the returned device, received on august 8th, 2016, was examined by orthofix (b)(4) quality engineering area.The device was subjected to visual and dimensional check as per orthofix design specifications.The visual check evidenced as follows: the pin, code 951001, in the back stop ring, code 100390, is not in its correct position; the washer, code 100391, is now damaged; the moving shank, code 500000, is not in its correct position (it is now apart from the head of the compressor screw, code 500004); the pin, code 100361, is now deformed; there is presence of rust on the threads and on the head of the compressor screw, code 500004.The device was then manipulated by forcing the moving shank, code 500000, to return to its correct position.This manoeuvre evidenced that the pin, code 951001, is not missing but damaged.The dimensional check evidenced that two dimensions of the device are now slightly out of specification (diameter of the hole in the back stop ring and diameter of the head of the compressor screw).However these differences could not have had any influences on the failure notified.A functional check was not performed as the device is broken and therefore not functioning anymore.The results of the technical evaluation concluded that an excessive load has been applied to the moving shank (code 500000) leading to the deformation the pin (code 951001), the detachment of the back stop (code 100390) and the subsequent sliding of the moving shank along the compressor screw (code 500004).This is confirmed also by the bending occurred on the pin, code 100361.Medical evaluation: the information made available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below a summary of the medical evaluations performed."in this case a (b)(6) boy was having lengthening and correction to the left femur.The surgeon used an lrs adv fixator with a swivelling clamp.It seems that the outrigger used to mount the cd unit for angular adjustment was used, and not the clamp cover.The cd unit was always stiff to use and finally broke after 3 weeks.The cd unit was replaced and treatment continues.Pages 29 to 30 of the lrs adv operative technique (ref: lr-0901-opt) explain fully the usage of this clamp.For lengthening, as here, the configuration should have been as on page 29.The surgeon should have used this configuration for the lengthening, and then changed to that shown on page 30 for the correction.The x-rays show a radio-opaque rail, possibly a standard 300 mm rail.There are just 2 clamps and it seems that it is a 'simple' 2 clamp lengthening with a later angular correction.The technical evaluation report shows that the cd unit broke because of excessive load; knowing the device this must have been a very considerable load.The excessive load was applied because of a particular factor relating to this application; possibly due to the configuration, or possible because the clamp locking nuts were not loosened prior to lengthening.Whatever the cause, this device was subjected to a load much more than the design specification, and failed.Final comments the results of the technical evaluation concluded that an excessive load has been applied to the moving shank (code 500000) leading to the deformation the pin (code 951001), the detachment of the back stop (code 100390) and the subsequent sliding of the moving shank along the compressor screw (code 500004).This is confirmed also by the bending occurred on the pin, code 100361.The medical evaluations evidenced as follows: "pages 29 to 30 of the lrs adv operative technique (ref: lr-0901-opt) explain fully the usage of this clamp.For lengthening, as here, the configuration should have been as on page 29.The surgeon should have used this configuration for the lengthening, and then changed to that shown on page 30 for the correction.The x-rays show a radio-opaque rail, possibly a standard 300 mm rail.There are just 2 clamps and it seems that it is a 'simple' 2 clamp lengthening with a later angular correction.The technical evaluation report shows that the cd unit broke because of excessive load; knowing the device this must have been a very considerable load.The excessive load was applied because of a particular factor relating to this application; possibly due to the configuration, or possible because the clamp locking nuts were not loosened prior to lengthening.Whatever the cause, this device was subjected to a load much more than the design specification, and failed".Based on the results of the technical evaluation and on the evidences deriving from the medical evaluations, orthofix (b)(4) can conclude that the problem that occurred is due to excessive load applied because of a particular factor relating to this application.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to this specific lot.Orthofix (b)(4) continues monitoring the devices on the market.
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The information provided by the local distributor indicates: product code: 50009.Batch number: (b)(4).Quantity: 1.Hospital name: (b)(6) hospital.Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2016.Body part to which device was applied: left femur.Surgery description: lengthening, correction.Patient information: (b)(6), male.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: the surgeon attached a fixator (lrs adv) to a patient for the lengthening and the correction of the femur.After one week of the operation, s/he started the lengthening of the fixator for a patient.The details of the lengthening were as follows.The lengthening was 1mm a day.(a quarter lap per once) (four times a day) the patient seemed to need considerable power for the turn of the cd unit from a start of the lengthening.After approximately three weeks, when a patient turned cd unit, a creak seemed to come to occur from cd unit.The cd unit was finally broken.The loss of the correction seemed to occur to a patient.The replacement to the cd unit (10-009) and re-lengthening seemed to be carried out for a patient.The surgeon asked jmc for an investigation about the cause that the cd unit was broken.Jmc confirmed the returned product was broken.Furthermore, we found the deformation of the pin.I will share it with you for your reference.Please kindly find some photos.Please investigate this if it has some issue.(additional information) the cd unit seemed to be connected to the outrigger of the micrometric swivelling clamp.The device failure had adverse effects on patient (loss of distraction/correction achieved).The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.A medical intervention was required (performed in (b)(6) 2016).Copies of the operative report are not available.Copies of the x-ray images are available.Patient current health condition: under treatment.(b)(4).
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