|
The information provided by local distributor indicates: products code: 53590 and 50008 (1 each): (mfr reports 9680825-2022-00007 and 9680825-2022-00008 respectively).Batch numbers: unknown and e104.Hospital name: (b)(4).Surgeon's name: dr (b)(6).Date of initial surgery: (b)(6) 2022.Body part to which device was applied: knee.Patient information: male.Problem observed during: into treatment/post-operative.Event description: "distraction of the knee.The initial operation occurred (b)(6) 2022, with lrs and special knee hinge, then, last week the knee hinge has broken and the surgeon had to change the device and also the distractor in two part 50008." the complaint report form also indicates: the device failure had adverse effects on patient (loss of achieved correction).The initial surgery was not completed with the device.A replacement device of same model was immediately available to complete surgery.The event did not lead to a delay in the duration of the surgical procedure.An additional surgery was required (no operation scheduled.The patient only required the replacement of the broken device).A medical intervention (outpatient clinic) was not required.Copies of the operative reports are available.Copies of the x-ray images are available.Product is available for return.Please also kindly refer to mfr report 9680825-2022-00008.Manufacturer reference number: (b)(4).
|
|
The information provided by local distributor indicates - products code: 53590 and 50008 (1 each) - (mfr reports 9680825-2022-00007 and 9680825-2022-00008 respectively) - batch numbers: f87 and e104 - hospital name: (b)(6) - surgeon's name: dr (b)(6) - date of initial surgery: (b)(6), 2022 - body part to which device was applied: knee - patient information: male - problem observed during: into treatment/post-operative - event description: "distraction of the knee.The initial operation occurred (b)(6), 2022, with lrs and special knee hinge, then, last week the knee hinge has broken and the surgeon had to change the device and also the distractor in two part 50008." the complaint report form also indicates: - the device failure had adverse effects on patient (loss of achieved correction) - the initial surgery was not completed with the device - a replacement device of same model was immediately available to complete surgery - the event did not lead to a delay in the duration of the surgical procedure - an additional surgery was required (no operation scheduled.The patient only required the replacement of the broken device) - a medical intervention (outpatient clinic) was not required - copies of the operative reports are available - copies of the x-ray images are available - product is available for return please also kindly refer to mfr report 9680825-2022-00008.Manufacturer reference number: (b)(4).
|
|
Analysis of historical records (mfr reports 9680825-2022-00007 and 9680825-2022-00008) orthofix srl checked the internal records related to the controls made on the knee hinge code 53590 batch f87 (lot laser marked on the component code 530590) before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of (b)(4) devices.According to orthofix srl historical records, no other notifications have been received from this specific device lot.Orthofix srl checked the internal records related to the controls made on the c/d unit code 50008 batch e104 (lot laser marked on the component code 500008) before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of 110 devices.According to orthofix srl historical records, no other notifications have been received from this specific device lot.Technical evaluation (mfr reports 9680825-2022-00007 and 9680825-2022-00008) the complained devices, received on may 20, 2022, were examined by orthofix srl quality operations department.The devices were subjected to visual and functional check as per orthofix srl specification.1).Device code 53590 batch f87 the visual check evidenced as follows: the knee hinge was received in disassembled condition due to the spacer separation.It was also evidenced that the fixing screw, component code 530590, is still inserted, despite the components separation.It seems that a high distraction force was applied to separate the parts.Some damaging signs are also visible on the peek central body.No issues were detected on the plastic distraction screw.A functional check was performed after the reassembly of the device.No issues were found.2).Device code 50008 batch e104 the visual check evidenced as follows: the c/d unit is disassembled in two parts.The internal threaded part was removed from the external tube.The internal threaded part is assembled by riveting it under the washer code 100391 that remained stuck inside the tubular part.The threaded part of the device is slightly damaged.A functional check was performed after the reassembly of the device.No issues were found apart the absence of the mechanical stop.Medical evaluation (mfr reports 9680825-2022-00007 and 9680825-2022-00008) the information made available on the event together with the results of the technical evaluation were sent to our medical consultant.Please find below an extract of the medical evaluations performed."in this case we are told that a knee hinge unit failed 9+ weeks after application, and a clicker cd unit 50008 also failed.The indications and patient details have not been provided.We are also told that alignment of the bones was lost, but that it was possible to replace the units immediately at a second operation with no subsequent loss of position.Because we are given no details it is impossible to estimate how much loading the knee hinge was given.We need to see some photos and x-rays of the application, and the age and weight of the patient and the operative indications, to understand why this happened.The technical report shows that the failure mechanism in each case was separation of a retaining washer leading to instability.In order for each screw to fail it must have been forced beyond the normal loading.We cannot suggest any more details without more information".Conclusion (mfr reports 9680825-2022-00007 and 9680825-2022-00008) from the results of the technical evaluation, it was concluded that both devices were originally conforming to orthofix specification.The technical analysis concluded that the knee hinge, code 53590, and the c/d unit, code 50008, have both been disassembled, since their mechanical stops have been forced during use.In both devices, respectively, the washer and the spacer are riveted to keep the component in position.If the devices are put in operation beyond their intended working range, mainly forcing them into distraction mode, the riveting may break leading to the separation of the components.A complete medical evaluation was not performed as no information about the medical procedure, patient diagnosis, patient details and x-ray images have been made available.Based on the information deriving from the technical analysis, orthofix can conclude that the failures occurred are mainly attributable to the conditions of use of the devices.Orthofix srl continues monitoring the devices on the market.
|
