On july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.The device involved in this event was manufactured by orthosonics ltd.Technical evaluation the system involved in this event has not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the device concerned.The technical evaluation 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 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 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: product code: os3000 (ultrasonic generator 230v ce).Serial number: (b)(4).Hospital name: (b)(6).Surgeon's name: (b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: n/a.Surgery description: arthroplasty revision.Patient's information: (b)(6) year-old, female problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "handpieces not working, tried combinations on both modules.Communication in email 7/7/20 from rep.: i believe the handpieces haven't been taken apart properly at the end of each case in preparation for processing, which can result in potential issues.When we plugged the handpieces into the generator and activated them, the generator didn't register them at all.".The complaint report form also indicated: the device failure had no adverse effects on patient the initial surgery was not completed with the device: manual removal of cement the event led to a delay in the duration of the surgical procedure: 1 hour.Difficulty on surgen's part an additional surgery was not required a medical intervention (outpatient clinic) was not required copy of operative reports and x-ray images are not available product is available for return no information was provided about patient current health conditions further information received from the local distributor on 21 july 2020: serial numbers of the handsets (b)(4) and (b)(4).Serial number of cables (b)(4).T is not possible to say where the issue comes from.The handsets were not being properly disassembled for processing, ie shroud and end cap were not removed for sterilisation.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).
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On july 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.The device involved in this event was manufactured by orthosonics ltd.Technical evaluation: the returned devices, received on 24th july 2020, were examined by orthofix srl quality engineering department.All devices were subjected to visual and functional check as per orthofix srl specification.The visual check evidenced as follows: 1.The ultrasonic generator, device code os3000 serial number (b)(6) , did not show any anomalies.2.In the cement removal handset, device code oh300/2 serial number (b)(6) , the washer and the nut on the rear end cap are missing.3.In the cement removal handset, device code oh300/2 serial number (b)(6) , the washer and the nut on the rear end cap are missing.The functional check evidenced as follows: 1.The ultrasonic generator, device code os3000 serial number (b)(6) is functioning properly.All checks performed passed.2.The cement removal handset, device code oh300/2 batch 3h4014, is not functioning properly.The sealing is lost from the rear connector.The handset is not detected by the generator.3.The cement removal handset, device code oh300/2 batch 3h4015, is not functioning properly.The sealing is lost from the rear connector.The handset is not detected by the generator.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: 14 july 2020.I understand that the hand sets that were to be used in this case were non functional from the beginning.Therefore the whole procedure of removing the prosthesis and the old cement would have been done by hand instruments.It is difficult to get an authentic estimate of the amount of extra time that this operation takes using hand instruments only.However as far as i can tell a revision of a hip prosthesis with a functioning oscar takes about 60 to 90 minutes, whereas an operation with hand instruments only take 2 to 3 hours.I think that the 'missed advantage' of not having the oscar includes having an operation that is 60 to 90 minutes longer, not just 30 minutes.That is what makes the oscar system such a game changer.So when the operation time has been extended by 1 hour because of a failure of the oscar system to work properly, i think that is about what i would expect in these circumstances.It sounds also as though the hand sets were not reprocessed correctly after the previous procedure, which may be relevant.7 august 2020 with the outcome of the technical analysis: both of these handsets have had a washer and nut removed from the rear end.This breaks the seal and allows water in during processing, and makes the handsets inoperative, which the tests confirmed.This conforms that they were both inoperative from the beginning.So this was a reprocessing failure.The generator is working normally.Final comments: the results of the technical evaluation concluded as follows: 1.The ultrasonic generator, device code os3000 serial number (b)(6) is functioning properly.All the tests performed passed.2.The failure found on the cement removal handsets, device code oh300/2 batch 3h4014 and batch 3h4015 is most likely to be attributable to water that entered inside the handset during cleaning and sterilization cycles.In both handsets the rear end cap, nut and washer are missing.This may be indicated as the root cause of this failure, as these components guarantee the isolation of the device from water infiltration.This may happen during an incorrect device handling during the storage and sterilization phase where the use is not in compliance with the instructions provided in the relevant ifu, ref.Pq osc.Orthofix srl continues monitoring the devices on the market.Please kindly also refer to mfr report number 9680825-2020-00046 and 9680825-2020-00047.
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The information provided by the local distributor indicates: - product code: os3000 (ultrasonic generator 230v ce).- serial number: (b)(6).- hospital name: (b)(6) hospital.- surgeon's name: mr.(b)(6).- date of initial surgery: (b)(6) 2020.- body part to which device was applied: n/a.- surgery description: arthroplasty revision.- patient's information: 55-year-old, female.- problem observed during: clinical use on patient/intraoperative.- type of problem: device functional problem.- event description: "handpieces not working, tried combinations on both modules.Communication in email 7/7/20 from rep.: i believe the handpieces haven't been taken apart properly at the end of each case in preparation for processing, which can result in potential issues.When we plugged the handpieces into the generator and activated them, the generator didn't register them at all.".The complaint report form also indicated: - the device failure had no adverse effects on patient.- the initial surgery was not completed with the device: manual removal of cement.- the event led to a delay in the duration of the surgical procedure: 1 hour.Difficulty on surgen's part.- an additional surgery was not required.- a medical intervention (outpatient clinic) was not required.- copy of operative reports and x-ray images are not available.- product is available for return.- no information was provided about patient current health conditions.Further information received from the local distributor on 21 july 2020: -serial numbers of the handsets (b)(6).-serial number of cables (b)(6).-it is not possible to say where the issue comes from.The handsets were not being properly disassembled for processing, ie shroud and end cap were not removed for sterilisation.Further information received from the local distributor on 23rd july 2020: -the patient is fine.Manufacturer reference number: 2020106.Distributor reference number: 404725.
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