| Model Number 91130 |
| Device Problem
Crack (1135)
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| Patient Problem
Oversedation (1990)
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| Event Date 04/20/2018 |
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Event Type
malfunction
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Manufacturer Narrative
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Analysis of historical records: the devices involved in this event have not yet been received by orthofix srl.Unfortunately also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: the devices concerned have not yet been received by orthofix srl.The technical evaluation will be performed as soon as the devices are received.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 evaluation 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.Please also kindly refer to mfr report 9680825-2018-00088.
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Event Description
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The information provided by the local distributor indicates: device code: (b)(4).Mfr report 9680825-2018-00088 respectively: batch number: unknown.Quantity: 1 each.Hospital name: (b)(6) hospital.Surgeon name: prof.(b)(6).Date of surgery: (b)(6) 2018.Body part to which device was applied: lower limb.Surgery description: other.Patient information: (b)(6), male, (b)(6), 170 cm.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: "the t wrench was cracked during the operation, it can't hold hydroxyapatite screw.The "operatine" time was increased.The professor was unhappy about that and the patient's anesthesia time was increased".The complaint report form also indicates: the device failure had adverse effects on patient.The surgery was not completed with the device.A replacement device was not immediately available to complete the surgery.The event led to a clinically relevant increase in the duration of the surgical procedure (use cutter hold the screw and slowly enter into it).An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-rays images are not available.Information about patient current health condition: no response.On october 8, 2018, orthofix srl received the following additional details: (b)(4).Patient is currently leave the hospital.On october 22, 2018, orthofix srl received the following additional information: the (b)(4) was sent back.In addition, because the product cannot be used directly, the delay time cannot be calculated.Manufacturer reference number: (b)(4).
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Manufacturer Narrative
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Analysis of historical records: device code: 91150: orthofix srl checked the internal records related to the controls made on the device code: 91150, lot: e141 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of 468 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint notified from this specific device lot.Device code: 91130: the device code: 91130 was not returned to orthofix srl.Unfortunately also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: on (b)(6) 2018 in regards to this event orthofix received only a universal t-wrench code: 91150, lot: e141.The returned device was examined by orthofix srl quality engineering department.The returned t-wrench was subjected to visual, dimensional and functional check as per orthofix specification.The visual check confirmed the problem notified: the device evidenced a crack on the upper part.The dimensional check did not evidence any anomalies.The functional check was performed using the gauge mm200.Despite the cracked part, the device still met the design specification.It was also performed a hardness test on the device.No anomalies have been found.The results of the technical evaluation concluded that the returned device (code: 91150) was originally conforming to orthofix specification.A technical evaluation of the second device involved, code: 91130, was not possible as the device was not returned.Medical evaluation: the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.On (b)(6) 2018: "it seems that in this case a surgeon was applying an xcaliber fixator.It was found that the t-wrench 91150 for inserting the screw was damaged during use and unusable.Also the screw connector 91130 could not be used.They therefore used the screw cutter to grip the screw and insert it.The operation was completed as planned but took longer than scheduled.The extended operating time (duration not known) may result in this being reported as a serious injury.The patient has come to no harm".On (b)(6) 2018 with the results of the technical evaluation: "these tests show that the t wrench concerned in this complaint was manufactured and assembled according to specifications.In fact the t-wrench concerned has a crack in the shaft close to the t handle.This is not complete, and tests during the technical analysis confirm that a bone screw can be gripped with a torque well over 15 nm/deg.As far as i can see the device although cracked, seems to work to specification.It is therefore not clear why the complaint stated that the device will not grip the bone screw.We should confirm that the surgeon was in fact using 6 mm orthofix bone screws.My view is that this operation could have been completed with this t-wrench.I suspect that the t-handle has developed a crack due to wear and tear of the device, but it still functions as specified".Final comments: the results of the technical evaluation concluded that the returned device (code 91150) was originally conforming to orthofix specification.A technical evaluation of the second device involved, code 91130, was not possible as the device was not returned.Should the device become available, the technical evaluation will be performed.The medical evaluation evidenced as follows: the patient has come to no harm.The t wrench concerned in this complaint was manufactured and assembled according to specifications.The device although cracked, seems to work to specification.We should confirm that the surgeon was in fact using 6 mm orthofix bone screws my view is that this operation could have been completed with this t-wrench.I suspect that the t-handle has developed a crack due to wear and tear of the device, but it still functions as specified.Based on the results of the technical evaluation, which confirmed the conformity of the returned device, and on the evidences deriving from the medical evaluation, orthofix can conclude that the t-handle crack due to wear and tear of the device, but it still functions as specified.The analysis of the historical data evidenced that no other notifications have been received on t-wrench belonging to this specific lot.Orthofix continues monitoring the products on the market.Please also kindly refer to mfr report: 9680825-2018-00088.
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Event Description
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The information provided by the local distributor indicates: device code: 91150 (universal t-wrench) and 91130 (screw connector) - mfr reports 9680825-2018-00088 and 9680825-2018-00089 respectively.Batch number: unknown.Quantity: 1 each.Hospital name: (b)(6).Surgeon name: prof.(b)(6).Date of surgery: on (b)(6) 2018.Body part to which device was applied: lower limb.Surgery description: other.Patient information: 34 years, male, 75 kg, 170 cm.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: "the t wrench was cracked during the operation, it can't hold hydroxyapatite screw.The operation time was increased.The professor was unhappy about that and the patient's anesthesia time was increased".The complaint report form also indicates: the device failure had adverse effects on patient.The surgery was not completed with the device.A replacement device was immediately available to complete the surgery.The event led to a clinically relevant increase in the duration of the surgical procedure (use cutter hold the screw and slowly enter into it).An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-rays images are not available.Information about patient current health condition: no response.On october 8, 2018, orthofix srl received the following additional details: device code: 91150: t position of wrench cracked.If you use the wrench to lock the screw again, it will split it into two.Device code: 91130: it can't hold hydroxyapatite screw.Patient is currently leave the hospital.On october 22, 2018, orthofix srl received the following additional information: the device code: 91150 was sent back.In addition, because the product cannot be used directly, the delay time cannot be calculated.Manufacturer reference number: (b)(4).
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