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In (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.(item involved in this event was manufactured by orthosonics ltd).Technical evaluation: the technical analysis on the returned devices, received by orthofix srl on (b)(6) 2018 is currently on going.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 investigation and/or further information are available.As soon as further information on the case and/or the outcome of the technical analysis is available, orthofix srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.(please kindly refer also to mfr report 9680825-2018-00038, mfr report 9680825-2018-00039, mfr report 9680825-2018-00040, mfr report 9680825-2018-00041).
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The information provided by the local distributor indicates: hospital name: hospital (b)(6).Surgeon's name: dr.(b)(6).Date of initial surgery: unknown.Body part to which device was applied: unknown.Surgery description: unavailable.Patient information: unavailable.Problem observed during: unavailable.Type of problem: unavailable.Event description: per the tm-hospital for joint disease owns these oscar iii handsets and according to the tm, the handsets are not registering on the console or have very low input on the console.Rep confirmed that all handsets were used in the same surgery.The hospital owns 4 trays.The delay was between 20-30 minutes waiting for a separate console and other trays to come up from sterile processing.There were no adverse effects to the patient.Replacement product was used to complete the surgery.Surgery was for total hip replacement.Patient information was not available.Further information received on april 25, 2018 from the distributor: the patient's information and x-rays are not available.The patient is stable.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).(please kindly refer also to mfr report 9680825-2018-00038, mfr report 9680825-2018-00039, mfr report 9680825-2018-00040, mfr report 9680825-2018-00041).
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The information provided by the local distributor indicates: - hospital name: hospital for (b)(4).- surgeon's name: dr.(b)(6).- date of initial surgery: unknown - body part to which device was applied: unknown - surgery description: unavailable - patient information: unavailable - problem observed during: unavailable - type of problem: unavailable - event description: per the tm-hospital for joint disease owns these oscar iii handsets and according to the tm, the handsets are not registering on the console or have very low input on the console.Rep confirmed that all handsets were used in the same surgery.The hospital owns 4 trays.The delay was between 20-30 minutes waiting for a separate console and other trays to come up from sterile processing.There were no adverse effects to the patient.Replacement product was used to complete the surgery.Surgery was for total hip replacement.Patient information was not available.Further information received on april 25, 2018 from the distributor: the patient's information and x-rays are not available.The patient is stable.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).(please kindly refer also to mfr report 9680825-2018-00038 follow up 1, mfr report 9680825-2018-00039 follow up 1, mfr report 9680825-2018-00040 follow up 1, mfr report 9680825-2018-00041 follow up 1).
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In 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.(item involved in this event was manufactured by orthosonics ltd).Technical evaluation the returned devices, received on (b)(6)2018, were examined by orthofix srl quality engineering department and then sent to the supplier 4easytech for the technical evaluation.1) bonecutter osteotome handset, device code ohb300/2 lot bhu0257: the visual check evidenced that the device is tampered on the rear connector and it is without the shroud.The device is not functioning properly.The ceramics inside are broken.The device does not work and a noise is produced when the handset is activated.The failure found on the handset, broken ceramics, is most likely to be attributable to water that entered inside the handset during cleaning and sterilization cycles.This may happen after multiple cleaning and sterilization cycles as a result of normal wear and tear or tampering of silicone o-rings.2) cement removal handset, device code oh300/2 lot 2hu2929: the visual check evidenced that the device is tampered near the flange and it is without the shroud.The device is not functioning properly.The sealing is lost from the flange, therefore the handset does not work.The generator shows "poor feedback" alert message.The failure found on the handset, the impossible detection by the generator, is most likely to be attributable to water that entered inside the handset during cleaning and sterilization cycles.This may happen after multiple cleaning and sterilization cycles as a result of normal wear and tear or tampering of silicone o-rings.3) cement removal handset, device code oh300/2 lot 3h0146: the visual check did not evidence any anomalies.The device is not functioning properly.The sealing is lost from the switch button, therefore the handset does not work.The generator shows "poor feedback" and "release all switches" alert messages.The failure found on the handset, related to seal lost from the switch button, is most likely to be attributable to water that entered inside the handset button switch during cleaning and sterilization cycles.This may happen after multiple cleaning and sterilization cycles as a result of normal wear and tear of silicone sealing that protects the button.4) cement removal handset, device code oh300/2 lot 2hu2930: the visual check evidenced some scratches on the shroud.They are likely related to the attempt to open the device.The flange is tampered.The device is not functioning properly.The sealing is lost from the rear body seal, therefore the handset does not work.The generator shows "poor feedback" alert message.The failure found on the handset, related to seal lost from the rear body seal, is most likely to be attributable to water that entered inside the handset during cleaning and sterilization cycles.This may happen after multiple cleaning and sterilization cycles as a result of normal wear and tear of silicone o-rings.5) cement removal handset, device code oh300/2 lot 2hu3353: the visual check did not evidence any anomalies.The device is not functioning properly.The sealing is lost from the rear body seal, therefore the handset does not work.The generator shows "poor feedback" alert message.The failure found on the handset, related to seal lost from the rear body seal, is most likely to be attributable to water that entered inside the handset during cleaning and sterilization cycles.This may happen after multiple cleaning and sterilization cycles as a result of normal wear and tear of silicone o-rings.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 evaluation: (b)(6)2018 in this case it seems that the hospital, who own a total of 4 oscar cement removal kits, found that none of the handsets were registering on the console when attached.A new console was brought up from sterile processing and the operation continued as planned.There was a delay of 20 to 30 minutes.We are not told, but must assume that the delay occurred after the patient's hip had been exposed and while the wound was open.In this case the delay is quite a long time to be added to the operation time.In another case, where a second console was not available, it would have been necessary to completely postpone the operation.It would be good practice for the surgeon to test the cement remover before starting the operation, especially if there is only one console available.(b)(6)2018 with the outcome of the technical analysis each of the handsets has been found to be non functional.3 of the handsets were processed improperly and two were found to be suffering from wear and tear and at the end of their life.Final comments the outcome of the technical investigation concluded that the failure occurred is mainly attributable to normal wear and tear of components inside the handsets.Orthofix srl historical records show that no other similar notifications have been received in regards to these specific device lots.Orthofix srl continues monitoring the devices on the market.(please kindly refer also to mfr report 9680825-2018-00038 follow up 1, mfr report 9680825-2018-00039 follow up 1, mfr report 9680825-2018-00040 follow up 1, mfr report 9680825-2018-00041 follow up 1).
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