| Model Number 50008 |
| Device Problem
Mechanical Problem (1384)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 02/06/2017 |
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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 50008 lot e69 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.Approx (b)(4) of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint received in regards to this specific device lot.Technical evaluation: the technical evaluation of the two devices involved in this event, received on march 1, 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 as soon as the results of the technical evaluation, currently on going, become available.As soon as the results of the technical evaluation become 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 9680825-2017-00008.Device under technical evaluation.
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Event Description
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The information provided by the local distributor indicates: device code: 50008 (standard c/d clicker model); batch numbers: e62 and e69 (mfr reports 9680825-2017-00008 and 9680825-2017-00009 respectively); quantity: 1 each; hospital name: (b)(6); surgeon name: dr.(b)(6); date of initial surgery: (b)(6) 2017; body part to which device was applied: tibia; surgery description: lengthening; patient information: (b)(6), male; problem observed during: clinical use on patient; type of problem: device functional problem.Event description: in this case, the ref 50008 was broken, at the small metal band level.I was with the surgeon, when he tried to do the lengthening, small metal part broke.He replaced with a second one which also broke.This second item is still on patient, i have to change the 14/2 directly in hospital in (b)(6).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; a replacement device was immediately available to complete the surgery; the event lead to a clinically relevant increase in the duration of the surgical procedure (25 minutes to find the problem and exchange the other one also broken); an additional surgery 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: good.On february 28, 2017, orthofix (b)(4) received the following additional information: how much lengthening was planned: "6cm"; which fixator was being applied: "lrs adult"; at what stage of the operation the fixator broke: "after 5 days when we just started the lengthening"; weight of the patient: (b)(6).On march 1, 2017, orthofix (b)(4) received the following clarification on the timing of failure and replacement: "the problem was for both distractor, when we tried to distract, we had some conflict and was very hard to turn and some metal came out from the distractor, we had in operating room a second distractor to change and happened the same, and couldn't distract.So just after the osteotomy, we had to let the bone 5 days before to start the lengthening, so had time to order a new distractor and ask the patient to come back and do the lengthening".Please also kindly refer to mfr report 9680825-2017-00008.(b)(4).
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Manufacturer Narrative
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Analysis of historical records (please also kindly refer to mfr report 9680825-2017-00008): orthofix (b)(4) checked the internal records related to the controls made on the device code 50008 lot e62 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 received in regards to this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the device code 50008 lot e69 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.Approx (b)(4) of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint received in regards to this specific device lot.Technical evaluation (please also kindly refer to mfr report 9680825-2017-00008): the returned devices, received on march 1, 2017 were examined by orthofix (b)(4) quality engineering area.The devices were subjected to visual, dimensional and functional check as per orthofix (b)(4) specification.- device batch e62: the visual, dimensional and functional check of the device batch e62 did not evidence any anomalies.The device still performs properly.- device batch e69: the visual check evidenced as follows: 1).The pin code 951001, that should seat in the back stop ring, component code 100390, is now missing.Also the back stop ring is not in its correct position; it is now in free movement.2).The moving shank, component code 500000, is not in its proper position; it is now detached from the head of the compressor screw (component code 500003).3).The compressor screw, component code 500003, is damaged.4).The hole, where the pin code 951001 should seat, is damaged.5).The threads of the component code 500003 (compressor screw) are slightly damaged.The dimensional check did not evidence any anomalies.The functional (sliding) check was then performed after positioning the moving shank (component code 500000) in its proper position.Both extreme positions can be reached; however the fluency of the sliding mechanism is not uniform along the thread probably due to the current damaging of the threads.From the results of the technical evaluation, it was concluded that: 1).The device batch e62 still performs properly and it could function as intended.2).The device batch e69 evidenced a damaged head with a missing retaining pin, and also the main threads that provide the compression/distraction action were damaged.These signs of damaging indicate that this device has been subject to significant wear and tear, and should have been withdrawn after the previous use.Medical evaluation (please also kindly refer to mfr report 9680825-2017-00008): 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 evaluations performed.February 28, 2017: "in this case we are told that a boy of (b)(6) was having a lengthening operation on a tibia.A cd unit 50008 was applied during the operation but apparently broke; a second unit was applied and also broke.We need to know how much lengthening was planned, which fixator was being applied, and at what stage of the operation the fixator broke.It would also be useful to know the weight of the patient: (b)(6) can vary from large adult to small child.During a normal operation for lengthening a fixator is applied and an osteotomy performed.A cd unit is distracted just a little to confirm that the osteotomy is complete, and then closed again.At no stage is the cd unit subjected to any significant load.I am therefore puzzled by this breakage and wonder if the cd units were faulty when applied".March 2, 2017 with the further information provided february 28, 2017 and march 1, 2017: "so this patient was adult size, and an adult lrs was quite appropriate.I just wonder if the osteotomy was complete.I guess that they would have told us if it was not.The instructions are always to check for a complete osteotomy by seeing a visible gap between the bone fragments, and if possible also showing some translation to confirm bone separation.Certainly this story might be compatible with this eventuality.Compression-distraction units are generally very robust, and a simple tibial lengthening should not cause any problems.We shall see when the technical analysis is complete.Something must have been wrong, either with the osteotomy or the cd units.Meanwhile this information makes the incident more understandable but does not provide an explanation as to why it happened".March 14 and 30, 2017 with the results of the technical evaluation: "it seems that the cd unit first used (batch e69) has a damaged head with a missing retaining pin, and also the main threads that provide the compression / distraction action were damaged.These various problems should have been discovered during the cleaning / disinfection / sterilisation process after the last use.Hospitals frequently outsource the instrument processing activities, so that they are done by people who are not familiar with the equipment.This means that the final quality control is not carried out at this stage, but at operation when the device is provided for use.This may mean at best a small delay while a replacement device is obtained, or a more serious delay or postponement of the procedure because of faulty instruments.This device has clearly been subject to significant wear and tear as part of its normal use, and should have been withdrawn after the previous use.This represents a failure of the preoperative checking system.The second device (batch e62) tests normally in this technical analysis.The complaint states: "he replaced with a second one which also broke".This is all the information that we have.The device was left on the patient and changed later.We do not have enough information to understand what happened with the second cd unit, but the poor processing of the first device suggests that there may have been faulty device preparation with the second.Cause of failure: 1st device batch e69: normal wear and tear; inadequate processing.2nd device batch e62: cause unknown as presented; device functions normally now, and may have jammed because of failure to clean the threads adequately".Final comments (please also kindly refer to mfr report 9680825-2017-00008): from the results of the technical evaluation, it was concluded that: 1).The device batch e62 still performs properly and it could function as intended.2).The device batch e69 evidenced a damaged head with a missing retaining pin, and also the main threads that provide the compression/distraction action were damaged.These signs of damaging indicate that this device has been subject to significant wear and tear, and should have been withdrawn after the previous use.The medical evaluation evidenced as follows: "it seems that the cd unit first used (batch e69) has a damaged head with a missing retaining pin, and also the main threads that provide the compression / distraction action were damaged.These various problems should have been discovered during the cleaning / disinfection / sterilisation process after the last use.This device has clearly been subject to significant wear and tear as part of its normal use, and should have been withdrawn after the previous use.This represents a failure of the preoperative checking system.The second device (batch e62) tests normally in this technical analysis.The complaint states: "he replaced with a second one which also broke".This is all the information that we have.The device was left on the patient and changed later.We do not have enough information to understand what happened with the second cd unit, but the poor processing of the first device suggests that there may have been faulty device preparation with the second.Cause of failure: 1st device batch e69: normal wear and tear; inadequate processing.2nd device batch e62: cause unknown as presented; device functions normally now, and may have jammed because of failure to clean the threads adequately".A complete medical evaluation was not performed as some information about the medical procedure was not made available, i.E.X-rays of the case.Based on the results of the technical evaluation and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is not device related.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.
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Event Description
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The information provided by the local distributor indicates: o device code: 50008 (standard c/d clicker model); o batch numbers: e62 and e69 (mfr reports 9680825-2017-00008 and 9680825-2017-00009 respectively); o quantity: 1 each; o hospital name: (b)(6); o surgeon name: dr.(b)(6); o date of initial surgery: (b)(6) 2017; o body part to which device was applied: tibia; o surgery description: lengthening; o patient information: (b)(6), male; o problem observed during: clinical use on patient; o type of problem: device functional problem.O event description: in this case, the ref 50008 was broken, at the small metal band level.I was with the surgeon, when he tried to do the lengthening, small metal part broke.He replaced with a second one which also broke.This second item is still on patient, i have to change the 14/2 directly in hospital in (b)(6).The complaint report form also indicates: o the device failure did not have any adverse effects on patient; o the initial surgery was completed with the device; o a replacement device was immediately available to complete the surgery; o the event lead to a clinically relevant increase in the duration of the surgical procedure (25 minutes to find the problem and exchange the other one also broken); o an additional surgery was not required; o copies of the operative reports are not available; o copies of the x-rays images are not available; o information about patient current health condition: good.On february 28, 2017, orthofix (b)(4) received the following additional information: 1.How much lengthening was planned? "6cm"; 2.Which fixator was being applied? "lrs adult"; 3.At what stage of the operation the fixator broke? "after 5 days when we just started the lengthening"; 4.Weight of the patient: "(b)(6)".On march 1, 2017, orthofix (b)(4) received the following clarification on the timing of failure and replacement: "the problem was for both distractor, when we tried to distract, we had some conflict and was very hard to turn and some metal came out from the distractor, we had in or a second distractor to change and happened the same, and couldn't distract.So just after the osteotomy, we had to let the bone 5 days before to start the lengthening, so had time to order a new distractor and ask the patient to come back and do the lengthening".Please also kindly refer to mfr report 9680825-2017-00008.(b)(4).
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Search Alerts/Recalls
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