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Analysis of historical records: (b)(4).(please also kindly refer to mfr report number 9680825-2015-00046).Technical evaluation: the technical evaluation on the returned device, received by orthofix srl on september 29, 2015 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 technical evaluation and/or further information on the case are available.As soon as the results of the technical evaluation are available, orthofix srl will provide you with 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: hospital name: (b)(6) hospital; surgeon name: mr.(b)(6); date of surgery: (b)(6) 2015; surgery description: lengthening (bilateral femoral lengthening); patient's information: (b)(6), female, (b)(6), previous health condition: ricketts; problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: cdu units have malfunctioned while being adjusted by patient.Threads appear to have welded or seized as unit is no longer adjustable.The complaint report form indicates: the device failure did not cause adverse effects to patient; the 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 not required; copies of the operative report are not available; copies of the xrays images are not available; information on patient current health condition: cdu's have been replaced and post operative treatment has continued, without any significant delay.(b)(4).
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Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 50008 lot e56 before the market release.No anomalies have been found.The original lot, manufactured in february 2015, was comprised of (b)(4) units.(b)(4) of them have already been distributed to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.(please also kindly refer to mfr report number 9680825-2015-00046 and mfr report number 9680825-2015-00052).Technical evaluation the returned devices, received on september 29 (lot e10 and lot 56), and on october 14 (lot e57), 2015 were examined by orthofix srl quality engineering department.The devices were subjected to visual and dimensional check as per orthofix srl design and product specifications.The visual check evidenced that the pin of device lot number e10 is bent.The devices lot number e56 and e57 do not evidence any visual defects.In the dimensional check on the three devices no anomalies were detected.It was then performed a functional check that confirmed that device lot number e57 is broken (separated) and that the devices lot number e10 and e56 are no more functioning.According to the quality control plan for this device, a functional check is performed on a 100% base.Therefore, the technical analysis performed concludes that the three devices were originally conforming to design specifications.No dimensional anomalies were detected.-device lot number e10: the problem notified could be mainly attributable to the use of the cd unit without unlocking the elastic locking pin, so it was deformed during previous uses.-device lot number e56: the problem notified could be mainly attributable to three different causes: 1.The device may have been damaged during use (due to strokes on it) 2.The device could have incorporated dirty particles into its threaded part 3.Missing of a regular lubrication of the device -device lot number e57: the problem notified could be mainly attributable to an excessive torque applied during the usage of the device causing the damage 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: "compression-distraction units have been an integral part of the orthofix external fixation system since its inception in the early 1980's.They are generally reused repeatedly, and are at times subjected to large loads during treatment for lengthening and limb reconstruction.They have proved a reliable instrument over the years, and the only modification that i am aware of has been to incorporate a clicker unit in the distraction mechanism.As far as i know the threaded bar and threaded barrel have remained the same over the years.When they do fail, they do so either because of inadequate maintenance so that dirt and debris get inside the threaded part and cause it to jam, or when the device is forcibly extended past the stop at the end of possible lengthening, and the two parts become separated.Since the clicker unit has been introduced, there is an occasional different cause of failure, and that is attempting to turn the nut to lengthen the cd unit without depressing the clicker unit button.And so it has proved in this case.The complaint form for the latest failure specifically states that the cd unit has become separated after being "fully distracted".Replacement cd units were applied and treatment continues.It seems to me that there must be a failure to comprehend the amount of lengthening available in a cd unit for this to have happened a second time in the same patient.What has happened in the past is that a surgeon fails to take into account the amount of lengthening of the cd unit that is required to get it into position before lengthening of the bone starts, thereby decreasing the amount of lengthening available when it is attached to the patient.It is normal for there to be some loss in the total lengthening capacity by the time that a cd unit has been adjusted so that it fits on the fixator." medical evaluation after the issuing of the technical analysis: "it seems that one cd unit was separated and two were jammed, one because the cd unit has been forced without depressing the clicker button, so that the retaining pin is bent, and one probably because of poor maintenance.The third was broken because excessive torque was applied to separate the two components.All three devices were originally released having fully passed a conformity test.Regrettably it is clear that the failure of these three cd units happened because of technical issues during manipulation of the devices either by the patient, the surgeons or the reprocessing staff.As the devices were replaced immediately in all cases, the treatment could continue and no harm came to the patient." final comments: the results of the technical evaluation evidenced that the returned devices were originally conforming to design specifications.The problems notified might be attributable to maintenance and use issues.The medical evaluation evidenced as follow: "the failure of these three cd units happened because of technical issues during manipulation of the devices either by the patient, the surgeons or the reprocessing staff.As the devices were replaced immediately in all cases, the treatment could continue and no harm came to the patient." based on the results of the technical evaluation performed on the returned devices, evidencing they were originally conforming to orthofix srl design specifications, and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem occurred is not device related.Orthofix srl continues monitoring the devices on the market.
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The information provided by the local distributor indicates: hospital name: (b)(6); surgeon name: mr.(b)(6); date of surgery: (b)(6) 2015; surgery description: lengthening (bilateral femoral lengthening); patient's information: (b)(6) old, female, (b)(6), previous health condition: ricketts; problem observed during: into treatment/post-operative; type of problem: device functional problem; event description: cdu units have malfunctioned while being adjusted by patient.Threads appear to have welded or seized as unit is no longer adjustable.The complaint report form indicates: the device failure did not cause adverse effects to patient; the 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 not required; copies of the operative report are not available; copies of the xrays images are not available; information on patient current health condition: cdu's have been replaced and post operative treatment has continued, without any significant delay.Further information received from the distributor on october 6, 2015: on (b)(4) 2015, it was observed in clinic a functional problem on a cd unit.Event description: "cd unit was described as "broken" over the phone between patient and nurse.In clinic cd unit was found to have become fully distracted and separated on the lrs rail.A washer can be heard moving loosely inside the main sleeve of the unit." the distributor reports that: the device failure did not cause adverse effects to patient; the event did not lead to a clinically relevant increase in the duration of the surgical procedure -lengthening adjustments again postponed; an additional surgery was not required; copies of the operative report are not available; copies of the xrays images are not available; information on patient current health condition: replacement cdu's have been used on the rail and lenghtening adjustments continue by the patient at home.(b)(4).
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