| Model Number 90022 |
| Device Problem
Mechanical Problem (1384)
|
| Patient Problem
No Code Available (3191)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 90022 lot v1377833 (lot laser marked on component 90022s, b14r) before the market release.No anomalies have been found.The original lot, manufactured in 2014, 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 concerned was received by orthofix (b)(4) on january 9, 2017.The technical evaluation on the returned device is currently on going.Medical evaluation the information available on the case was sent to our medical evaluator.A preliminary clinical evaluation was performed and will be finalized once the results of the technical evaluation are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Evaluation in progress.
|
| |
|
Event Description
|
|
The information provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: left femur surgery description: correction patient's information: (b)(6), female, weight (b)(6); previous health condition: perthes disease problem observed during: into treatment/post-operative; type of problem: device functional problem/clinical (patient) problem; event description: during (b)(6) holiday, the axis in the fixator joint loosened.When the patient visited the hospital (b)(6), it was found that a failure of the joint mechanism had occurred.Removal surgery performed (b)(6).No harm to the patient was discovered and the hip joint showed good mobility regarding rotation, abduction, adduction, flexion and extension.According to the medical records in the hospital, all the components were new when the first surgery was performed.The complaint report form indicates: the device failure had no adverse effects on patient; the initial surgery was completed with used device; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required following device failure - date: (b)(6) 2016; copies of the operative report are available; copies of the xrays images are not available; information on patient current health condition: n/a notes and comments: original operative report in (b)(6).Translated summary provided by the distributor.Further information from the summary translated into english of the operative report: "girl (b)(6).Late in development, bone status more like a 9 yrs old child.Treatment for perthe's disease.First surgery made (b)(6) 2016.Original plan was to remove the ex fix in the beginning of (b)(6) 2017." on january 3, 2017 the distributor provided a picture of the device involved and the following further information: "the lot no of the full component (art no 90022) is v1377833 and the lot no on the body part is b14r.More specific regarding the failure, it's the ball-bearing components that are loose.Both rings are rattling and moving.During the surgery (b)(6), the device was removed and no other device was applied.The patient will start the rehab program as soon as the patient is painless.(after the removal of the ex fix, the cavities after the screws were cleaned to encourage growth of new bone).The patient is allowed to walk with crutches for three weeks, to unburden the hip." on january 5, 2017 orthofix (b)(4) received the following further information from the distributor: "there are some interesting signs of wear, inside the hinge mechanism, that maybe could give us a clue what did happen.The ball-bearing joint lost the fixation.A quick manual examination by swemac, we found that the ball-bearing components are compromised - there is slack in the joint and the motion is unpredictable when the joint randomly get stuck.It's the hinge with the ball-bearing components, that has collapsed." on january 20, 2017 orthofix (b)(4) received from the distributor a copy of pre and post operative x-ray images.(b)(4).
|
| |
|
Manufacturer Narrative
|
|
Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 90022 lot v1377833 (lot laser marked on component 90022s, b14r) before the market release.No anomalies have been found.The original lot, manufactured in 2014, 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 returned device, received on january 9th, 2017 was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and dimensional check as per orthofix (b)(4) design and product specifications.The visual check performed confirmed that there are signs of wear on the device, probably due to the normal usage of the device.The dimensional check did not evidence any anomalies.In the functional check it was noticed a little play between the components and that the movement is not as fluid as the one of a not used device.Nevertheless, the device can be considered as still performing properly.The movement of the clamp is the result of the normal wear and tear of the device.The results of the technical evaluation evidenced that the device was originally conforming to orthofix (b)(4) design specifications and it is still performing properly.The failure occurred could be mainly attributable to wear and tear of the device.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) 2017 "the 90022 module has been available ever since the procallus fixator was produced in the 1990's.The object of this module is to allow fixation across the hip joint while allowing movement of the hip, in flexion / extension only.This is called arthrodiastasis.The use of this module for the treatment of perthe's disease of the hip is well established.Perthe's disease is a spontaneous devascularisation of the femoral head in growing children, that results in the partial or complete loss of bony material inside the femoral head, which becomes flattened and asymmetrical to a variable extent.The bone recovers its vascularity but not its shape, which can lead to severe early osteoarthritis of the affected joint.The principle is to apply the fixator with 2 or 3 screws in the femoral shaft, and 2 or 3 in the pelvis.The fixator is applied after a kirschner wire has been inserted into the centre of the femoral head, and the cannulated articulation is applied over the k wire and the fixator then acts as a template for screw insertion, so that the fixator joint is aligned with the hip joint.After application the fixator is distracted to unload the hip joint.The object is to allow the child continued mobility with an unloaded hip joint, which may recover its vascularity without the flattening from weightbearing, and result in a much more normal joint.This patient is quite typical of this condition, and is well within the weight parameters.Normally the patient is told to walk partially weightbearing with crutches, to avoid excessive load on the bone screws.The fixator is left on the patient for 3 or more months.In this patient the fixator was in place for just over 4 months, so it can be considered that the treatment was completed.Therefore, i do not think that the patient came to any harm, and should have benefited from this treatment.I think that it is likely that this patient stressed the joints of this fixator beyond their design criteria by being active and mobile.It is very difficult to constrain a lively and fit child to limit their mobility.Curiously, the increased mobility of the fixator joint may have allowed the patient to regain full joint mobility while still being distracted." on (b)(6) 2017 "the fixator was applied for precisely 17 weeks in this patient.The initial x-ray shows typical perthes disease of the left hip involving the central part of the femoral epiphysis.The shape of the femoral head is still good (i.E.It has not begun to collapse), and this is an excellent case for arthrodiastasis.The fixator has been applied in absolutely text book fashion, except for the fact that the axis of rotation is slightly distal.This means that the femoral head will move antero-posteriorly during flexion and extension.This would have put some strain on the articulation, which might have been significant.I suspect that the correct reason for the failure may be the slight articular misalignment together with some excess loading of the device by the patient." final comments: the results of the technical evaluation evidenced that the device was originally conforming to orthofix (b)(4) design specifications and it is still performing properly.The medical evaluation evidenced as follows: "in this patient the fixator was in place for just over 4 months, so it can be considered that the treatment was completed.Therefore, i do not think that the patient came to any harm, and should have benefited from this treatment.I think that it is likely that this patient stressed the joints of this fixator beyond their design criteria by being active and mobile.I suspect that the correct reason for the failure may be the slight articular misalignment together with some excess loading of the device by the patient." based on the results of the technical evaluation performed on the returned device, that evidenced its conformity to orthofix (b)(4) specifications, and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem occurred is not device related.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix (b)(4) continues monitoring the devices on the market.
|
| |
|
Event Description
|
|
The information provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: left femur.Surgery description: correction.Patient's information: (b)(6), female, weight (b)(6); previous health condition: perthes disease problem observed during: into treatment/post-operative; type of problem: device functional problem/clinical (patient) problem; event description: during christmas holiday, the axis in the fixator joint loosened.When the patient visited the hospital (b)(6), it was found that a failure of the joint mechanism had occurred.Removal surgery performed (b)(6).No harm to the patient was discovered and the hip joint showed good mobility regarding rotation, abduction, adduction, flexion and extension.According to the medical records in the hospital, all the components were new when the first surgery was performed.The complaint report form indicates: the device failure had no adverse effects on patient; the initial surgery was completed with used device; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was required following device failure - date: (b)(6) 2016; copies of the operative report are available; copies of the xrays images are not available; information on patient current health condition: n/a.Notes and comments: original operative report in swedish.Translated summary provided by the distributor.Further information from the summary translated into english of the operative report: "girl (b)(6).Late in development, bone status more like a (b)(6) child.Treatment for perthe's disease.First surgery made (b)(6) 2016.Original plan was to remove the ex fix in the beginning of (b)(6) 2017." on january 3, 2017 the distributor provided a picture of the device involved and the following further information: "the lot no of the full component (art no 90022) is v1377833 and the lot no on the body part is b14r.More specific regarding the failure, it's the ball-bearing components that are loose.Both rings are rattling and moving.During the surgery (b)(6), the device was removed and no other device was applied.The patient will start the rehab program as soon as the patient is painless.(after the removal of the ex fix, the cavities after the screws were cleaned to encourage growth of new bone).The patient is allowed to walk with crutches for three weeks, to unburden the hip." on january 5, 2017 orthofix (b)(4) received the following further information, included in a ppt presentation of the device, received from the distributor: "there are some interesting signs of wear, inside the hinge mechanism, that maybe could give us a clue what did happen.The ball-bearing joint lost the fixation.A quick manual examination by swemac, we found that the ball-bearing components are compromised - there is slack in the joint and the motion is unpredictable when the joint randomly get stuck.It's the hinge with the ball-bearing components, that has collapsed." on january 20, 2017 orthofix (b)(4) received from the distributor a copy of pre and post operative x-ray images.(b)(4).
|
| |
|
Search Alerts/Recalls
|
|
