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Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 193337 batch g001 before the market release.No anomalies have been found.The original lot, manufactured in 2017 was comprised of 30 devices.All of them have already been distributed to the market.Technical evaluation: the involved device was received on 12th february 2020 by orthofix srl quality engineering department.The technical evaluation is in progress.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 srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.(b)(4).
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The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon's name: dr.(b)(6).Date of implantation surgery: (b)(6) 2018 in (b)(6).Date of removal surgery: (b)(6) 2020.Body part to which device was applied: femur.Surgery description: n/a.Patient's information: female, (b)(6) year-old, weight (b)(6) kg, height (b)(6) cm, previous health condition: good.Problem observed during: on scheduled device removal.Type of problem: device functional problem.Event description: removal of a chimaera nail failed.It is a long nail and all screws (except the lag screw) are already out.The lag screw was not able to remove with the normal device.So they use the screw extractor.While using the tip breaks.The tip of the screw extractor is in the head of the lag screw.The patient need urgent knee prosthesis and therefore the long nail has to be removed.The surgery could not be completed.Another surgery has to be planned.The complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was not completed with the device.A replacement device was not immediately available to complete surgery: the surgery could not be completed.The event led to a clinically relevant increase in the duration of the surgical procedure: a new surgery to remove the nail is necessary.An additional surgery is required: the date has to be planned after answer from orthofix for a new surgery instruction/special device for extraction.A medical intervention (outpatient clinic) was not required.Copies of the operative report are not available.Copies of the x-ray images are available.Patient current health conditions: good.Further information received from the local distributor on 10th february 2020: "the tip of the screw extractor is still in the screw and the screw and the nail are still in the patient."normal device" is the device shown at fig.82 in the operative technique for nail extraction.As i know the end cap is reintegrated." further information received from the local distributor on 19th february 2020: the implant on patient includes one nail chimaera hfs long nail right 130 ° l340mm d11mm sterile code 99-t933340r lot b1075240 and one lag screw chimaera hfs lag screw sliding l105mm sterile code 99-t93705 lot b1249679.Manufacturer reference number: (b)(4).Distributor reference number: (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 193337 batch g001 before the market release.No anomalies have been found.The original lot, manufactured in 2017 was comprised of 30 devices.All of them have already been distributed to the market.Technical evaluation the returned device, received on (b)(6) 2020 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 confirmed that the screw extractor is broken and that some threads are damaged.The dimensional check did not evidence any anomalies, with the exception of the thread length.Approx.20 mm of the thread are missing (still in the screw).It was not possible to perform the functional check as the device is broken.The device was then sent to an external laboratory for the failure analysis investigation: the images from the fractographic analysis suggest that the failure is related to a flexural over load due to the brittle aspect of the facture surface.The control of the raw material confirmed that the device was originally conforming to design specifications (x15 tn).Medical evaluation 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: -(b)(6) 2020.In this case from germany a female adult patient, age unknown, was having an operation to remove a femoral intramedullary nail.This is a long chimaera nail with a single sliding lag screw.2 distal locking screws have been removed.The nail cap has also been removed.The original fracture has completely healed.The nail must be removed because the patient requires a knee prosthesis.Attempts to remove the lag screw failed.They tried to use the lag screwdriver and retention rod short, 193283 and 193280, but this apparently did not work, so they tried the screw extractor 193337.The tip of the screw extractor has broken off inside the head of the lag screw.They therefore abandoned the surgery and are asking for further advice.I wonder if the head of the lag screw was damaged during the insertion? this patient now needs to have another operation to remove the lag screw and nail.I am not aware of any dedicated instrument to help remove this lag screw.Use of another screw extractor is blocked.I suspect that the lag screw head must be exposed sufficiently to allow an instrument to grip it, so that it can be turned out.Needle-nosed pliers of a suitable size should do it.-(b)(6) 2020 with the outcome of the technical analysis this is an interesting report on the screw extractor.The device was clearly used beyond the device criteria.Final comments the results of the technical evaluation evidenced that the device was originally conforming to orthofix srl design specifications.The screw extractor was broken at approximately 20 mm from the tip.This may be attributable to the application of an excessive flexural load during the extraction phase of the screw.The issue notified is related to a flexural overload.Orthofix srl would like to inform that a new screw extractor has been created, specifically designed for this case in order to remove the implant.The new screw extractor use will be presented to the surgeon for his approval and then supplied to the hospital as soon as the covid-19 disease restrictions prohibiting access to hospitals, will allow it.Orthofix srl continues monitoring the devices on the market.- attachment: [2020038_fda medwatch cover letter follow up 1.Pdf].
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