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Analysis of historical records (revised information): at the receiving of the device, orthofix (b)(4) evidenced that the lot number marked on the component is b148, instead of b51 as originally communicated by the customer.Orthofix (b)(4) checked the internal records related to the controls made on the device code m511 lot b1057046 (lot marked on component b148) before the market release.No anomalies have been found.The original lot, manufactured in 2016, 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.Technical evaluation: the device, received on february 28th, 2017 was returned by customer cleaned and sterilized, but some residuals of biological tissue were still present, so the device, considered as contaminated, was sent to an external laboratory to complete decontamination.The device, received on march 21st, 2017, from the external laboratory, was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and functional check as per orthofix (b)(4) specification.The visual check evidenced several signs of contamination on the screws of the device.Despite the decontamination performed at an external laboratory, some residuals could not be removed completely.The functional check performed before the decontamination activity evidenced that the sliders extreme positions can be reached, whereas the device allows rotation only in one plane.The functional check performed after the decontamination activity evidenced that the rotation that initially was not allowed could be performed.However, a torque extremely higher than the one required on a fixator in standard conditions had to be used to complete the rotation.The mechanism responsible of this movement was dismantled and resulted damaged and contaminated.Although the device was decontaminated twice, there were still traces of contamination on the rotation mechanism.From the results of the technical analysis it was concluded that without the residuals the device should have performed properly.Although after the second decontamination, both device rotations could be reached, it was noticed that the torque required for one rotation is higher than the one intended by design specifications, probably due to the damaged mechanism discovered disassembling the device and to the contamination that could not be removed.The damage detected may be attributable to contamination particles on mechanism teeth.The contamination did not allow sub-components to move as intended.The mechanism, forced to move, was damaged.Then, the combination of contamination and damaged mechanism hampered the rotation of the device in one plane.Orthofix (b)(4)l technical evaluation can conclude that the high level of residuals on moving mechanism did not allow the device to perform properly.When this amount of contamination is reached, the device should be cleaned prior usage or discarded.Medical evaluation: the information 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.(b)(6) 2017 in this case of a child of (b)(6) with radial deficiency, an m511 was to be applied to a patient, but it was found that the gears did not seem to move correctly when it was on the patient.The problem seemed to get worse to the point that the fixator seemed to be jammed.They therefore removed the fixator and placed an m512 which will not achieve the original goals.They intend to use another m511 in the near future.It is very difficult to say exactly what happened here, but it is very likely that this fixator will show signs of wear or possibly that there was organic debris in the gears; something to cause the gears to be difficult to be stiff.March 29, 2017 with the results of the technical evaluation: in this case a multiplanar mini-rail m511 was tested initially on the nurses table and found to function normally.When applied to the patient it jammed and in spite of several attempts could not be used.There are various points to make: the shriners hospitals in the usa are charity hospitals, and reuse fixation equipment just as in most european hospitals.-this device, the non functioning m511, was returned visibly contaminated, so it was sent to an external laboratory to be processed.-as i understand it from the technical analysis, the functional tests on the device were performed before the device was sent to an external laboratory for decontamination.To complete the functional tests the device was sent for a second decontamination and cleaning and at that point it was possible to complete the angular movement, but only with considerably greater torque that would be normally expected.This device has been used at least once before and presumably worked as expected, because no complaint was made.-the visible contamination of this device was extensive and obvious.This is even after the device had been cleaned at the point of use in the usa.Besides the contamination, it looks to me as though the gear on the rotation mechanism is damaged.-much of the contamination was external and should have been removed by any complete cleaning operation.Some of it was internal inside the gear mechanism.I think that the use was correct (application in a (b)(6) year old patient for radial aplasia).The processing was incorrect: this device should not have been accepted for reuse after the previous application; the device was obviously contaminated and may have been before this attempted usage; i do not think that this device could have passed all of the functional tests performed as described "the m2 was tested on the back table for radial/ulnar - dorsal/palmar gradual motion".I think that this device failed because of inadequate cleaning and incorrect processing.I should add a comment about the 30 minute delay.A 30 minute delay in an operation that would normally take 30 - 60 minutes should probably be regarded as significant, but i am sure that this patient would have come to no harm as a result.Final comments: from the results of the technical analysis it was concluded that the damage detected may be attributable to the presence of contamination particles on mechanism teeth.The contamination did not allow sub-components to move as intended.The mechanism, forced to move, was damaged.Then, the combination of contamination and damaged mechanism hampered the rotation of the device in one plane.Orthofix (b)(4) technical evaluation confirmed that the high level of residuals on moving mechanism did not allow the device to perform properly.When this amount of contamination is reached, the device should be cleaned prior usage or discarded.Please consider that all devices should be carefully checked before clinical use, as reported in orthofix instructions for use pq isp in the section "inspection, maintenance and testing": "all instruments and product components should be visually inspected for cleanness and any signs of deterioration that may cause failure in use (such as cracks or damage to surfaces) and functions tested before being sterilized" the medical evaluation evidenced as follow: i think that the use was correct (application in a (b)(6) year old patient for radial aplasia).The processing was incorrect: this device should not have been accepted for reuse after the previous application; the device was obviously contaminated and may have been before this attempted usage.I think that this device failed because of inadequate cleaning and incorrect processing.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 attributable to incorrect decontamination processing.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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The information provided by the local distributor indicates: hospital name: (b)(6); surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2017; body part to which device was applied: l ulna; surgery description: correction; patient's information: (b)(6) years old, male; previous health condition: radial deficiency - wrist centralization; problem observed during: clinical use on patient; type of problem: device functional problem; event description: per the tm-- the m2 was tested on the back table for radial/ulnar - dorsal/palmer gradual motion.Once applied on the patient, the fixator seemed to be jammed up.We removed of the patient, ensured everything was loose (locking bolt) and re-applied.Removed again, changed the orientation (distal to proximal and visa versa) and problem persisted.The fixator was at this point barely able to move even when off the patient.Compression/distraction of clamps was never an issue.We removed the m2 and placed a static m512 in place and attempted to do minimal acute correction.It felt as if the gears were not fluid and grinding within the fixator.Patient will be scheduled for new m@ to be applied so further correction can be completed.The complaint report form indicates: the device failure had adverse effects on patient; the initial surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event led to a clinically relevant increase in the duration of the surgical procedure -another surgery; an additional surgery was required following device failure; copies of the operative report are not available; copies of the xrays images are not available; information on patient current health condition: date of second surgery is tbd.Further information received from the distributor on february 21, 2017: time increase of the surgery: there was a 30 minute.In the initial surgery the m511 (lot b51) was put on then removed and replaced with the m512.In the revision surgery which took place on (b)(6) 2017, the m512 was removed and another m511 was put on.The m511 worked the second time.(b)(4).
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