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Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93130 batch b1693150 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the available cut off part of the nail, has not yet been received by orthofix (b)(4).Orthofix (b)(4) is strictly in contact with the local distributor to have the cut off part of the device concerned.The technical evaluation will be performed as soon as the device becomes available.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 investigation are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.
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The information initially provided by the local distributor indicated: product code: 99-t93130.Batch number: b1693150.Date of initial surgery: (b)(6) 2022.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient information: 68 years, male, revision knee replacement.Problem observed during: clinical use on patient/intraoperative.Event description: product was modified by surgeon and technical workshop intra operatively to make it fit in the patient's femur.The incident occurred right at the beginning of the procedure when the guide wire was inserted and it got stuck.Upon further imaging investigation it was discovered that the patient has a revision knee implant with a stem running from the distal end to the proximal half of the femur as well a cement mantle.The wire couldn't be advanced any further and this meant that the nail could not be inserted as per intended approach.The major issue was that our implant would be too long and that it could not inserted to the desired depth as per subscribed use.On 27 april 2022, the doctor informed me that there was loss of correction in the patient.However, he will leave the nail in and monitor fracture healing.The complaint report form also indicates: the device failure had adverse effects on patient (loss of fracture reduction, loss of achieved correction).The initial surgery was completed with the device.The event led to a delay in the duration of the surgical procedure (total delay: 30 minutes).An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-ray images are available.The cut off part of the nail is available for return.Patient is stable in hospital at time of this report but experiencing pain and discomfort.(b)(4).
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The information provided by the local distributor indicated: product code: 99-t93130 batch number: b1693150 date of initial surgery: (b)(6), 2022 body part to which device was applied: femur surgery description: fracture treatment patient information: 68 years, male, revision knee replacement- problem observed during: clinical use on patient/intraoperative.Event description: product was modified by surgeon and technical workshop intra operatively to make it fit in the patient's femur.The incident occurred right at the beginning of the procedure when the guide wire was inserted and it got stuck.Upon further imaging investigation it was discovered that the patient has a revision knee implant with a stem running from the distal end to the proximal half of the femur as well a cement mantle.The wire couldn't be advanced any further and this meant that the nail could not be inserted as per intended approach.The major issue was that our implant would be too long and that it could not inserted to the desired depth as per subscribed use.On (b)(6) 2022, the doctor informed me that there was loss of correction in the patient.However, he will leave the nail in and monitor fracture healing.The complaint report form also indicates: the device failure had adverse effects on patient (loss of fracture reduction, loss of achieved correction) the initial surgery was completed with the device the event led to a delay in the duration of the surgical procedure (total delay: 30 minutes) an additional surgery was not required a medical intervention (outpatient clinic) was not required copies of the operative reports are not available copies of the x-ray images are available the cut off part of the nail is available for return patient is stable in hospital at time of this report but experiencing pain and discomfort manufacturer ref: (b)(4).Distributor ref: (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 99-t93130 batch b1693150 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of 15 devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation the cut off part of the nail, received on june 14, 2022, was examined by orthofix quality operations department.The returned portion was subjected to visual, dimensional and functional check.The visual check of the portion received evidenced that the distal part of the nail was cut.So the nail was implanted without distal locking screws.The dimensional check, performed where possible, did not evidence any anomalies.The functional check, performed where possible, did not evidence any anomalies.It was also performed the verification of the raw material certificate used to produce this nail.No issues were found.Medical evaluation the information made available on the case were sent to our medical evaluator.Please find below an extract of the medical evaluation performed."it seems that in this case a 68 year old male patient sustained a trochanteric fracture of the left femur.According to the description that he was taken to the operating theatre with a plan to insert a chimaera nail.The prosthesis would be visible on any x-ray of the hip.They state clearly that the intention was to insert an intact chimaera nail, but it should have been obvious that an intact nail would not fit in the space remaining in the proximal femur.From the 2 images which were taken at the same time, the distance between the tip of the final implant and the end of the cement mantle is about 15 mm, possible less.It seems that the surgeon arranged for the distal end of the chimaera nail to be cut off, so that the nail had space only for the proximal lag screws.The complaint states that the "incident" occurred when they inserted the guide wire which then became stuck in the cement mantle of the prosthesis.It seems that they only discovered about the prosthesis at that point.The surgeon was informed that it was not advised to modify the implant as this would lead to an absence of distal locking holes.The surgeon took responsibility and the implant was shortened.It is clear from the x-ray images that the fracture was immobilised initially, but we are told that there was some loss of position at a later date (not specified).Comments: i would suggest that a better solution would have been to use the pertrochanteric fixator with ha coated bone screws.This prosthesis has not been inserted quite deep enough, and the reason is that the cement mantle below it in fact prevents any further insertion.The lag screw is not long enough, and if it had been a little more distal could have been joined by a supplementary lag screw, which should have increased stability.This fracture repair may fall apart, but would not be the fault of the implant which was modified to the point where it lost most of its stability.In this case the component (in this case the chimaera nail) did not fail.It was intentionally cut off the original implant to allow it to fit inside the bone.What is extraordinary is that it seems that the surgeon inserted the guide wire before checking the medullary canal (possibly without an image intensifier).I agree that this was not a good solution to the clinical situation.The technical report has confirmed that the nail structure was within the design criteria".Conclusion the results of the technical analysis, performed on the returned portion of the nail, concluded that the device was originally conforming to orthofix specification.The medical evaluation evidenced as follows: "i would suggest that a better solution would have been to use the pertrochanteric fixator with ha coated bone screws.This prosthesis has not been inserted quite deep enough, and the reason is that the cement mantle below it in fact prevents any further insertion.The lag screw is not long enough, and if it had been a little more distal could have been joined by a supplementary lag screw, which should have increased stability.This fracture repair may fall apart, but would not be the fault of the implant which was modified to the point where it lost most of its stability.In this case the component (in this case the chimaera nail) did not fail.It was intentionally cut off the original implant to allow it to fit inside the bone.What is extraordinary is that it seems that the surgeon inserted the guide wire before checking the medullary canal (possibly without an image intensifier).I agree that this was not a good solution to the clinical situation.The technical report has confirmed that the nail structure was within the design criteria".Based on the results of the technical evaluation and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem that occurred is not device related.Orthofix srl historical records shows that no other notifications have been received in regards to this specific device lot.Orthofix srl continues monitoring the devices on the market.
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