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On july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision.Therefore, orthofix (b)(4) is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd.The devices involved in this event were manufactured by orthosonics ltd.Technical evaluation: the devices involved in this event have not yet been received by orthofix (b)(4).Orthofix (b)(4) is strictly in contact with the local distributor to have the devices concerned.The technical evaluation will be performed as soon as the devices 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 technical 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.Please also kindly refer to mfr reports 9680825-2019-00031/32/34/35/36.(b)(4).
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The information provided by the local distributor indicates: products code: 1 handset code oh300/2 batch 3h4026 (mfr report 9680825-2019-00031); 1 handset code oh300/2 batch 3h4033 (mfr report 9680825-2019-00032); 1 cable code ch300, batch ch2299 (mfr report 9680825-2019-00033); 1 cable code ch300, batch ch2298 (mfr report 9680825-2019-00034); 1 ultrasonic generator code os3000, batch 3g4014 (mfr report 9680825-2019-00035); 1 ultrasonic generator code os3000, batch 3g4010 (mfr report 9680825-2019-00036).Hospital name: (b)(6) hospital.Surgeon name: mr.(b)(6).Date of initial surgery: (b)(6) 2019.Body part to which device was applied: no response.Surgery description: other.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "handset not functioning correctly, serial numbers provided over the phone (b)(4), and cables (b)(4).They were tried with both generators 3g4014 and 3g4010.The patient was having a revision hip replacement when the said equipment stopped working.The procedure had to be abandoned and the patient had to be rescheduled for today ((b)(6) 2019) to finish the operation".The complaint report form also indicated: 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 had to be abandoned and the patient had to come back to theatre on (b)(6) 2019 to finish the procedure).The event led to a clinically relevant increase in the duration of the surgical procedure (the patient had another operation on another date, subjecting the patient to another round of anaesthesia and days in hospital).An additional surgery was required (performed on (b)(6) 2019).A medical intervention (outpatient clinic) was not required.Copies of the operative report are not available.Copies of the x-ray images are not available.Patient current health conditions: the patient has been reschedule to have the second stage of his surgery today (b)(6) 2019.(b)(4).
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On (b)(6) 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 devices involved in this event were manufactured by orthosonics ltd.Technical evaluation the returned devices, received on (b)(6) 2019, 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 did not evidence any anomalies.The functional check evidenced as follows: 1).The cement removal handsets, device code (b)(4).The cables code ch300 (b)(4).And the generator code os3000 (b)(4).Are functioning properly.No issues have been detected.2).The oscar iii generator device code os3000 batch 3g4010, is not functioning properly.On the digital power module pm300 (b)(4).Floating components (the transformer or the inductor) are detected.This caused the "poor feedback release all switches" message on the display.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) 2019 in this case a patient (details not specified) was having a revision of a hip prosthesis.The handsets stopped working and were tried with two different generators.The decision was made to abandon the surgery and reschedule it for 3 days later.In this case it was decided for reasons unspecified that it was not possible to continue the surgery with hand instruments.It is inevitable that this will happen increasingly, because surgeons will become less skilled as the use of hand instruments for revision hip surgery.In this case there is no plan b, and the surgeon is completely reliant on the cement removal system.The patient suffers from an increased risk of complications, particularly infection or venous thrombosis.However, delicate instruments are bound to fail from time to time.(b)(6) 2019 with the outcome of the technical analysis two cement removal handsets, two oscar generators and two cables were returned for evaluation.The complaint stated that both handsets were tried with both generators using both cables.However the report is clear that only one of the generators is faulty, and that the other five devices work fully to specification.This will be upsetting news for the surgeon, but it seems clear that the diagnosis of device failure may have been premature.The generator that did fail did so because of (probably) rough handling during transport.Final comments.On (b)(6) 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 devices involved in this event were manufactured by orthosonics ltd.The results of the technical evaluation concluded as follows: 1).The cement removal handsets, devices code (b)(4)., the cables code ch300 (b)(4).And ch2299 and the generator code os3000 (b)(4).Are functioning properly.No issues have been detected.2).The failure found on the generator, device code os3000 (b)(4).Is attributable to an accidental impact probably occurred during device handling or due to the shipping conditions of the device.Based on the results of the technical evaluation performed on the returned devices, and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem occurred is related to the conditions of use of the devices.Orthofix srl continues monitoring the devices on the market.Please also kindly refer to mfr reports 9680825-2019-00031/32/34/35/36.- attachment: [2019084_fda medwatch cover letter_follow up 1.Pdf].
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The information provided by the local distributor indicates: products code: 1 handset code oh300/2 batch 3h4026 (mfr report 9680825-2019-00031); 1 handset code oh300/2 batch 3h4033 (mfr report 9680825-2019-00032); 1 cable code ch300 batch ch2299 (mfr report 9680825-2019-00033); 1 cable code ch300 batch ch2298 (mfr report 9680825-2019-00034); 1 ultrasonic generator code os3000 batch 3g4014 (mfr report 9680825-2019-00035); 1 ultrasonic generator code os3000 batch 3g4010 (mfr report 9680825-2019-00036) hospital name: (b)(6) hospital.Surgeon name: (b)(6).Date of initial surgery: (b)(6) 2019.Body part to which device was applied: no response.Surgery description: other.Patient information: n.A.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "handset not functioning correctly, serial numbers provided over the phone (b)(4).They were tried with both generators (b)(4).The patient was having a revision hip replacement when the said equipment stopped working.The procedure had to be abandoned and the patient had to be rescheduled for today ((b)(6) 2019) to finish the operation".The complaint report form also indicated: 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 had to be abandoned and the patient had to come back to theatre on (b)(6) 2019 to finish the procedure).The event led to a clinically relevant increase in the duration of the surgical procedure (the patient had another operation on another date, subjecting the patient to another round of anaesthesia and days in hospital) an additional surgery was required (performed on (b)(6) 2019) a medical intervention (outpatient clinic) was not required copies of the operative report are not available copies of the x-ray images are not available patient current health conditions: the patient has been reschedule to have the second stage of his surgery today (b)(6) 2019.No other information was provided.Manufacturer reference number: (b)(4).Distributor reference number:(b)(4).
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