| Model Number 30008 |
| Device Problem
Mechanical Problem (1384)
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| Patient Problem
No Code Available (3191)
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| Event Date 01/27/2017 |
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Event Type
Injury
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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 device code 30008 lot 079 before the market release.No anomalies have been found.The original lot, manufactured in 1999, 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.Technical evaluation: the technical evaluation of the device involved, received on february 20, 2017, 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 technical investigation will be 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.Device evaluation currently on going.
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Event Description
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The information initially provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon name: dr (b)(6); date of initial surgery: (b)(6) 2017; body part to which device was applied: not provided; surgery description: lengthening; patient information: (b)(6) male treated for limb lengthening; problem observed during: into treatment/post-operative; type of problem: device functional problem.Event description: c/d unit was difficult to distract and while distracting the end piece of the unit popped off.The complaint report form also indicates: the device failure did not have any adverse effects on patient; the initial surgery was completed with the device; no clinically relevant increase in the duration of the surgical procedure; an additional surgery was required (performed on (b)(6) 2017); a medical intervention (outpatient clinic) was not required; copies of the operative reports are not available; copies of the x-rays images are not available; information about patient current health condition: not provided.On february 13, 2017, orthofix (b)(4) received information about the lot number of the device concerned: lot 079.On february 20, 2017, orthofix (b)(4) received the following additional information on the event: body part to which device was applied- "right leg"; date of device failure- "(b)(6) 2017"; planned treatment (total lengthening planned and lengthening achieved before device failure) - "planned for 50 days"; details of the intervention, type of osteotomy, initial distraction- "limb lengthening"; programmed and performed lengthening (starting date, distraction speed) -"start date about one week post- operative, 1mm per day"; copies of the operative reports - "rep has not been able to get from surgeon"; copies of the pre and post-operative x-ray images (initial surgery and revision one) - "rep has not been able to get from surgeon"; can we please also know what fixator was used? - "paediatric lrs (short)"; please provide information about patient current health condition- "patient is currently doing well".On february 21, 2017, orthofix (b)(4) received copies of the operative report.(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 device code 30008 lot 079 before the market release.No anomalies have been found.The original lot, manufactured in 1999, 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.Technical evaluation the returned device, received on february 20th, 2017 was examined by orthofix (b)(4) quality engineering area.The device was subjected to visual, dimensional and functional check as per orthofix (b)(4) specification.The visual check evidenced as follows: the end stopper, component code 300365, has come out from its seat.Moreover its surface is damaged.The female part of the device, component code 300301, is broken in correspondence to the hole that assembles the pin, component code 300360.Moreover, the inner surface where the end stopper should seated is damaged.The pin, component code 300360, is bent.The dimensional check of the returned device, performed where possible, did not evidence any anomalies apart from the hole of the female part which is now slight over dimension due to the fact it is now broken.The functional check (sliding test), performed where possible, did not evidence any anomalies.The results of the technical evaluation concluded that the breakage of the female part code 300301, the bending of the pin code 300360, and the detachment of the end stopper code 300360 are all evidences of an excessive load applied to the device.The returned device was originally conforming to orthofix specification.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 an extract of the medical evaluation performed.On february 10, 2017: "in this case we do not know the indication for use, the type of lengthening or the timescale of any of the usual operative steps.We cannot possibly evaluate why this has happened.Failure of these units is extremely rare and when it happens is usually due to the unit being extended past the mechanical stop.The history here suggests that, but we must wait and see.The report states that the patient was not affected but required a second surgery.These statements are not compatible.We must assume that this patient suffered a serious injury, whatever the cause of the failure of the cd unit to perform as expected.No doubt we will receive the unit in due course and be able to answer some of the questions, but we do require more clinical information as requested".On february 22, 2017 with the further information and the operative report: "the patient had a 46 mm limb length discrepancy.A paediatric lrs rail was being applied to the right femur to correct this.We are not told what the lengthening goal was, but we might assume that they at least wished to resolve the full discrepancy.The 30008 unit extends fully by 50 mm.The procedure would only have been successful if the unit had been more or less completely closed at the time of application, otherwise there would not have been 46 mm of length available.Nearly always, the cd unit is a little bit open at the beginning of lengthening.If the surgeon had used the 55008 cd unit there would have been 62 mm available, which would probably have been enough.It is very likely therefore that this cd unit was extended past its working length during the final stages of lengthening.The operation record shows that the application was completed in an excellent manner, completely according to the operative technique".On march 8, 2017 with the results of the technical evaluation: "the technical analysis shows clearly that the cd unit in question was distracted beyond its normal range so that the end stopper was forced off.The reason for this is probably that the cd unit was applied with more than 4 mm of distraction, and therefore it was not possible for it to reach the required 46 mm of distraction to neutralise the length discrepancy, as we suspected".Final comments: the results of the technical evaluation concluded that the breakage of the female part code 300301, the bending of the pin code 300360, and the detachment of the end stopper code 300360 are all evidences of an excessive load applied to the device.The returned device was originally conforming to orthofix specification.The medical evaluation evidenced as follow: "the patient had a 46 mm limb length discrepancy.A paediatric lrs rail was being applied to the right femur to correct this.We are not told what the lengthening goal was, but we might assume that they at least wished to resolve the full discrepancy.The 30008 unit extends fully by 50 mm.The procedure would only have been successful if the unit had been more or less completely closed at the time of application, otherwise there would not have been 46 mm of length available.Nearly always the cd unit is a little bit open at the beginning of lengthening.If the surgeon had used the 55008 cd unit there would have been 62 mm available, which would probably have been enough.It is very likely therefore that this cd unit was extended past its working length during the final stages of lengthening.The operation record shows that the application was completed in an excellent manner, completely according to the operative technique.The technical analysis shows clearly that the cd unit in question was distracted beyond its normal range so that the end stopper was forced off.The reason for this is probably that the cd unit was applied with more than 4 mm of distraction, and therefore it was not possible for it to reach the required 46 mm of distraction to neutralise the length discrepancy, as we suspected".Based on the results of the technical evaluation and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the cd unit failed because of excessive load.Orthofix (b)(4) historical records shows that no other notifications have been received in regards to this specific device lot.Orthofix (b)(4) continues monitoring the devices on the market.
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Event Description
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The information initially provided by the local distributor indicates: - hospital name: (b)(6) hospital; - surgeon name: dr (b)(6); - date of initial surgery: (b)(6) 2017; - body part to which device was applied: not provided; - surgery description: lengthening; - patient information: (b)(6) male treated for limb lengthening; - problem observed during: into treatment/post-operative; - type of problem: device functional problem.- event description: c/d unit was difficult to distract and while distracting the end piece of the unit popped off.The complaint report form also indicates: - the device failure did not have any adverse effects on patient; - the initial surgery was completed with the device; - no clinically relevant increase in the duration of the surgical procedure; - an additional surgery was required (performed on (b)(6) 2017); - a medical intervention (outpatient clinic) was not required; - copies of the operative reports are not available; - copies of the x-rays images are not available; - information about patient current health condition: not provided.On february 13, 2017, orthofix (b)(4) received information about the lot number of the device concerned: lot 079.On february 20, 2017, orthofix (b)(4) received the following additional information on the event: body part to which device was applied- "right leg".Date of device failure- "(b)(6) 2017".Planned treatment (total lengthening planned and lengthening achieved before device failure) - "planned for 50 days".Details of the intervention, type of osteotomy, initial distraction- "limb lengthening".Programmed and performed lengthening (starting date, distraction speed) -"start date about one week post- operative, 1 mm per day".Copies of the operative reports - "rep has not been able to get from surgeon".Copies of the pre and post-operative x-ray images (initial surgery and revision one) - "rep has not been able to get from surgeon".Can we please also know what fixator was used? - "paediatric lrs (short)".Please provide information about patient current health condition- "patient is currently doing well".On february 21, 2017, orthofix (b)(4) received copies of the operative report.(b)(4).
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