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Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 184000 (component code 184000s lot x1917) before the market release.No anomalies have been found.The original lot, manufactured in 2011, was comprised of 18 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint notified from this specific device lot.Technical evaluation the technical evaluation on the returned device, received on january 08, 2016, is currently on going.Medical evaluation the information available on the case was sent to our medical evaluator.A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation and/or further information on the case are available.Orthofix srl has requested further information on the event such as copy of x-ray images and patient current health condition.Unfortunately, this information has not yet made available.As soon as further information and/or the results of the technical evaluation are 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: (b)(6); date of initial surgery: (b)(6) 2015; surgery description: fracture treatment; patient information: (b)(6), female, condition patient was being treated for: intertroch hip fracture; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: screwdriver end piece (capture rod knob) came off and detached from the screwdriver when dr tonks tried to detach the screwdriver from the screw.The knob just twisted off right in his hands.The complaint report form indicates: the device failure had no adverse effects on patient; the surgery could not be completed with used device; a replacement device was not immediately available to complete surgery -had to have a replacement unit flashed from distributor spare set.Hospital only keeps one set in house so nothing else was sterile.The event led to a clinically relevant increase in the duration of the surgical procedure: 45 minutes; an additional surgery was not required; copies of the operative reports are available (not received); copies of the xrays images are available (not received); patient current health condition: unknown.On (b)(6) 2015 orthofix srl received the following information from the distributor: "our customer service department was notified on 11/25 about the complaint.However they had not received details (which were provided on the completed product complaint form) until 12/22.Once they received the completed product complaint form from the rep, the complaint was then entered into the system and the compliant handling team was notified." (b)(4).
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Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 184000 (component code (b)(4) lot x1917) before the market release.No anomalies have been found.The original lot, manufactured in 2011, was comprised of 18 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint notified from this specific device lot.Technical evaluation; the returned device, received on (b)(6) 2016 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 dimensional check did not evidence any issues.The visual check evidenced that a neck screw was engaged to the screwdriver.As evidenced during the visual checks it was confirmed that the screw was jammed into the device.The threaded connection in the screw was not correctly engaged; this is confirmed by the slight misalignment between the screw and the screwdriver.This caused the cross-threading of the parts.It was then performed a functional check, which confirmed that the device was not functioning anymore.The devices were jammed and during the tests, the head of the instrument fell down.The same test was then performed on one instrument taken from orthofix srl stock.Please consider that to engage in the right way the screw, the screw has to be positioned in the appropriate tool.In the notified case it was most likely not used the appropriate tool to engage the screw.As a consequence of this, the screw jammed into the device.Furthermore, to unlock the device it was most likely forced the instrument causing the breakage of the same.Orthofix srl technical analysis concluded that the failure observed is most likely to be attributable to a not proper use of the device.During the engagement of the neck screw, it was most likely not used the right tool, causing the jamming of the screw into the device.It was then forced the screwdriver causing the breakage of the head of the screwdriver as well.The information made available on the event, together with the results of the technical analysis was sent to our medical evaluator.Please find below an extract of the medical evaluations performed."an operation was being conducted to fix a trochanteric fracture in an (b)(6) year old female with the pc.C.P.This a correct indication for this implant.During a routine procedure the knob of the neck screwdriver became detached so that the instrument could not be used.A second screwdriver was available but had to be cleaned and sterilised.After this the operation proceeded normally.The delay added 45 minutes to the procedure.I do not consider that the patient came to any harm, as the operation was completed as originally planned with pc.C.P fixation of the fracture.However, these operations normally take less than one hour, frequently less than 45 minutes, so the extra time in this case must be regarded as significant.However, it would not have led to a permanent damage to the body structure.Even in the very worst case, if they could not use a pc.C.P there are many other implants that could have been used.In this case the operation was completed as planned but took longer because of the need to find another screwdriver.It is possible that the knob was forcibly removed or its attachment damaged during the cleaning process after the previous surgery, but this is conjecture." "the technical analysis on this case shows clearly that the thread that engages with the head of a cephalic screw was crossed inside a screw head and as a result became jammed.The knob on this threaded rod then broke off during manipulations to remove it.I agree that this is most likely to happen if the screwdriver is not applied to the screw in a vertical manner, as described in the technique.We can therefore regard this incident as a technical problem related only to this particular operation." the results of the technical evaluation concluded that the failure observed is most likely to be attributable to a not proper use of the device.During the engagement of the neck screw, it was most likely not used the right tool for the engagement of the screw, causing the jamming of the screw into the device.It was then forced the screwdriver causing the breakage of the head of the screwdriver as well.The medical evaluation evidenced as follow: "the technical analysis on this case shows clearly that the thread that engages with the head of a cephalic screw was crossed inside a screw head and as a result became jammed.The knob on this threaded rod then broke off during manipulations to remove it.I agree that this is most likely to happen if the screwdriver is not applied to the screw in a vertical manner, as described in the technique.We can therefore regard this incident as a technical problem related only to this particular operation." according to the evidences deriving from the technical analysis and from the medical evaluation performed, orthofix srl would like to remind the importance of following the instructions reported on the product operative technique, ref.Pm pcp the got fried pc.C.P for percutaneous compression plating of pertrochanteric hip fractures.Based on the results of the technical evaluation performed on the returned device, and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem occurred is not device related.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.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) medical center, (b)(6); surgeon name: (b)(6); date of initial surgery: (b)(6) 2015; surgery description: fracture treatment; patient information: (b)(6) years old, female, condition patient was being treated for: intertroch hip fracture; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: screwdriver end piece (capture rod knob) came off and detached from the screwdriver when dr tonks tried to detach the screwdriver from the screw.The knob just twisted off right in his hands.The complaint report form indicates: the device failure had no adverse effects on patient; the surgery could not be completed with used device; a replacement device was not immediately available to complete surgery.Had to have a replacement unit flashed from distributor spare set.Hospital only keeps one set in house so nothing else was sterile.The event led to a clinically relevant increase in the duration of the surgical procedure: 45 minutes; an additional surgery was not required; copies of the operative reports are available (not received); copies of the xrays images are available (not received); patient current health condition: unknown.On (b)(6) 2015 orthofix srl received the following information from the distributor: "our customer service department was notified on (b)(6) about the complaint.However they had not received details (which were provided on the completed product complaint form) until (b)(6).Once they received the completed product complaint form from the rep, the complaint was then entered into the system and the compliant handling team was notified." manufacturer reference number: (b)(4).Distributor reference number: (b)(4).
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