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Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code ohs2080su, lot b1255002 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation: the device involved in this event has not been received at orthofix (b)(4) yet.The technical evaluation will be performed once the device is returned.Medical evaluation: the information 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 technical investigation are available.As soon as the results of the investigation become available, orthofix (b)(4) will provide you with a follow up report.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 surgery: (b)(6) 2018; body part to which device was applied: femur; patient information: (b)(6) year-old, female, previous health condition: intervention on pth problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: (b)(6)-year-old patient managed for pth revision for stem loosening.The ablation of the cement is carried out with the oscar ablation system from orthofix.The device "scrapper probe" broke in the femur of the patient.The head of the device remained stuck in the femoral shaft.The complaint report form also indicates: the device failure had adverse effects on patient: longer intervention time.Risk of having to perform a femorotomy if the head of the device could not be removed.The surgery was not completed with the device.The event led to a clinically relevant increase in the duration of the surgical procedure: longer intervention time.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 not available.On (b)(4) 2018, the local distributor provided a copy of x-ray images taken on (b)(6) 2018 and the following further information: patient's weight and height: (b)(6).Prolongation of surgery time: 30 min.The head of the probe had been put off with hard conditions.Patient's current health condition: post operative situation has been simple and patient went out from hospital by (b)(6) 2018.(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 ohs2080su lot b1255002 (lot g180288 marked on the component) before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 20 devices.All of them have already been released to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical evaluation: the returned device, received on 2nd january 2019, was examined by orthofix srl quality engineering department.The returned device was subjected to visual and dimensional check as per orthofix srl specification and then sent to an external laboratory for the raw material check and failure analysis.The visual check evidenced that the single use 8mm scraper probe is broken at about 71,81 mm from thread bottom.The tip of the device shows presence of residuals (cement) and some scratches and marks.The dimensional check, performed where possible, did not evidence any anomalies.It was not possible to perform the functional check as the device is broken.The analysis of the raw material, performed by an external laboratory, confirmed that the item is in conformity with orthofix specifications.The fractographic clues indicate a unidirectional bending fatigue fracture, with origin in correspondence of wear or impact marks.Such marks cause the local intensification of the stresses acting on the probe (ultrasound or manual stresses) leading to fatigue breakage.Medical evaluation: the information made 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.On (b)(6) 2018 in this case from france a 63 year old female patient, 75 kg and 1.65 m tall, was admitted for revision of a hip prosthesis.The oscar system was used for cement removal.A single use scraper probe ohs2080su broke during this procedure and the distal end was stuck in the remaining cement.We can be sure that by this time the first prosthesis had been removed.A 30 minute delay was caused by this event.The patient was discharged in good condition 4 days postoperatively.An xray shows a femoral prosthesis in place.It is impossible to know the timing of this xray, but we must assume that it is of the replacement prosthesis.There is no sign of any probe component remaining.The translations of the surgeon's report to the relevant authority is: "ablation of the cement is carried out with the ablation system oscar from orthofix.The device "scrapper probe "broke in the femur of the patient.Device remained stuck in the femoral shaft.Longer intervention time.Risk of having to perform a femorotomy if the head of the device could not be removed.The device is available for expertise." the end of this statement confirms that the broken piece of the probe has been removed.We can therefore understand that the cement removal was complicated by breakage of a probe which became stuck in the remaining cement.After a 30 minute delay the broken part was removed, the remaining cement removed and a replacement prosthesis was inserted.Therefore the operation was completed as expected, and i do not think that the patient came to any harm.Breakage of a probe is a known risk in this type of case and warnings are provided in the operative technique and instructions for use to avoid bending the probe and avoid contact with metal while activated.When a probe becomes stuck in the remaining cement and breaks, as here, it is normally possible to use a different probe to loosen the surrounding cement and remove the incarcerated fragment.It is unusual for a femorotomy to be necessary.In this case the broken piece was removed, presumably by removing the cement from round it with a new probe.We are not told the complete sequence of events in this case, and it is difficult to evaluate it fully.The delay of 30 minutes is not very long in the context of a hip prosthesis revision, and i would suggest that this event was a problem, not a complication; a problem that has been foreseen by the manufacturer and should not cause the patient harm.On (b)(6) 2019 with the results of the technical evaluation: this report suggests that the scraper probe in question had been in contact with some metal so that the probe had been subjected to rapid fatigue failure at an area of stress.This was related to the way that the device was being used in this particular case.It also confirms that the device was originally supplied to specification.The conclusion of this technical analysis does not change the previous conclusions that the device broke because of particular usage in an individual case.Final comments: the results of the technical evaluation confirmed that the device was originally conforming to orthofix srl design specifications.The fractographic clues indicate a unidirectional bending fatigue fracture, with origin in correspondence of wear or impact marks.Such marks cause the local intensification of the stresses acting on the probe (ultrasound or manual stresses) leading to fatigue breakage.We may suppose that there was a casespecific factor contributing to the breakage, such as the accidental contact with hard materials during clinical use.The analysis of the historical data evidenced that no other similar 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).Surgeon's name: dr.(b)(6).Date of surgery: (b)(6) 2018 body part to which device was applied: femur.Patient information: 63 yearold, female, previous health condition: intervention on pth.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: 63yearold patient managed for pth revision for stem loosening.The ablation of the cement is carried out with the oscar ablation system from orthofix.The device "scrapper probe" broke in the femur of the patient.The head of the device remained stuck in the femoral shaft.The complaint report form also indicates: the device failure had adverse effects on patient: longer intervention time.Risk of having to perform a femorotomy if the head of the device could not be removed.The surgery was not completed with the device.The event led to a clinically relevant increase in the duration of the surgical procedure: longer intervention time.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 xray images are not available.On 14 november 2018, the local distributor provided a copy of xray images taken on (b)(6) 2018 and the following further information: patient's weight and height: 75kg and 165cm.Prolongation of surgery time: 30 min.The head of the probe had been put off with hard conditions.Patient's current health condition: post operative situation has been simple and patient went out from hospital by (b)(6) 2018.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).
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