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Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code m511 lot v1360076 (lot laser marked on component 600523, b123) before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4) devices.All of them have already been distributed to the market.Technical evaluation: the technical evaluation of the device involved will be performed as soon as the device become available.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation is being performed and will be finalized once the results of the technical evaluation are available.As soon as further information and/or the results of the technical investigation become available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.
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The information provided by the local distributor indicates: hospital name: (b)(6); surgeon name: mr (b)(6) (orthopaedic consultant) and (b)(6) (plastics consultant); date of surgery: (b)(6) 2015; body part to which device was applied: left hand; surgery description: correction; patient's information: (b)(6), female; problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: "the patient is doing ok but because the locking screw does not work, a lot of the correction of angulation is lost.I have speeded up her correction this week on the basis that a lot of the correction is being lost because there is not way of stopping revertion to the previous position.I think what happened is that when the parents tightened the locking bolt for the angular correction, the captive nut on the underside of the frame twisted out of the shallow notch it is in and in doing so deformed and essentially jammed on the thread so that it cannot be tightened or loosened.I am hoping we can still get the coronal angular correction done but the fixator will need to be locked at this point otherwise we will just loose the position." the complaint report form indicates: the device failure did not cause adverse effects to patient; the surgery was completed with used device; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required: (b)(6) 2015; copies of operative reports are not available; copies of the xrays images are not available; patient current health condition: the surgeon advised case went well.Note and comments: the patient has bilateral club hands which are being corrected (this case is the first hand) - will require additional surgery for second club hand.(b)(4).
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Analysis of historical records (information already provided) orthofix srl checked the internal records related to the controls made on the device code m511 lot v1360076 (lot laser marked on component 600523, b123) before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of 62 devices.All of them have already been distributed to the market.Technical evaluation (new information) the returned device, received on november 24, 2015 was examined by orthofix srl quality engineering department.The device was subjected to visual and dimensional check as per orthofix srl design and product specifications.The visual check evidenced that the seat for one of the locking screws is damaged, therefore the movement of that gear cannot be stopped.The dimensional check did not evidence any anomalies.The functional check confirmed that the locking of the gear where the screw seat is damaged is not functioning.The device performs properly for all other extents.Orthofix failure analysis concluded that the device was originally conforming to design specifications.The damage detected may be mainly attributable to incorrect use of the locking screw.Medical evaluation (new information) the information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluations: "this patient of (b)(6) has bilateral club hand, and the first hand is being treated with an m511, which is quite appropriate.In this case it seems that the correction is taking place but the radio-ulnar locking screw has become jammed in some way.The surgeon states that some correction is being lost but that this is being compensated by faster correction.They state that there are no adverse effects on the patient, and surgery could be completed with the used device.It is therefore not completely clear what is happening.However i note that the family must loosen the locking nut, make the correction then retighten the locking nut each time they make a correction.If this is not done in the correct order i wonder if there might be a problem, as noted above." final comments the results of the technical evaluation evidenced that the returned device was originally conforming to design specifications.The damage detected may be mainly attributable to incorrect use of the locking screw.The medical evaluation evidenced as follow: "i note that the family must loosen the locking nut, make the correction then retighten the locking nut each time they make a correction.If this is not done in the correct order i wonder if there might be a problem, as noted above." as a general information, orthofix srl recommends to : loosen the locking screw.Care should be taken not to loosen too much.If the locking screw is loosened too much, the nut comes out from its seat and keeps spinning without locking, thus stripping the seat of the locking screw.Correct and/or adjust before tightening the locking screw again, verify the position of the captive nut, which has to be in its seat.If not, the nut gets jammed.Based on the results of the technical evaluation performed on the returned device, that evidenced its conformity to orthofix srl specifications, and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem occurred is not device related.Orthofix srl continues monitoring the devices on the market.
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The information provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon name: mr (b)(6) (orthopaedic consultant) and (b)(6) (plastics consultant); date of surgery: (b)(6) 2015; body part to which device was applied: left hand; surgery description: correction; patient's information: (b)(6), female; problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: "the patient is doing ok but because the locking screw does not work, a lot of the correction of angulation is lost.I have speeded up her correction this week on the basis that a lot of the correction is being lost because there is not way of stopping revertion to the previous position.I think what happened is that when the parents tightened the locking bolt for the angular correction, the captive nut on the underside of the frame twisted out of the shallow notch it is in and in doing so deformed and essentially jammed on the thread so that it cannot be tightened or loosened.I am hoping we can still get the coronal angular correction done but the fixator will need to be locked at this point otherwise we will just loose the position." the complaint report form indicates: the device failure did not cause adverse effects to patient; the surgery was completed with used device; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required: (b)(6) 2015; copies of operative reports are not available; copies of the xrays images are not available; patient current health condition: the surgeon advised case went well.Note and comments: the patient has bilateral club hands which are being corrected (this case is the first hand) - will require additional surgery for second club hand.(b)(4).
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