| Model Number 172200 |
| Device Problem
Mechanical Problem (1384)
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| Patient Problem
Device Embedded In Tissue or Plaque (3165)
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| Event Date 04/10/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 172200 batch 6426930001 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first breakage complained in regards to this specific device lot.Technical evaluation: the technical evaluation on the returned device, received on may 2, 2017 is currently on going.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, currently on going, become available.As soon as the results of the investigation will be available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Device under technical evaluation.
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Event Description
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The information provided by the local distributor indicates: - device code: 172200 (nitinol reamer shafts with ao coupling); - batch number: 6426930001; - quantity: 1; - hospital name: (b)(6); - surgeon's name: not provided (b)(6); - date of surgery: (b)(6) 2017; - body part to which device was applied: not provided; - surgery description: fracture treatment; - patient information: (b)(6), male; - problem observed during: clinical use on patient/intraoperative; - type of problem: device functional problem; - event description: "a reamer diameter 9 mm got broken during surgery.Some parts left in patient body / in a (b)(6) patient during surgery for a fracture of the tibia and an open fracture of the femur on the right, the orthofix reamer broke inside the patient's femur".The complaint report form also indicates: - the device failure had adverse effects on patient (un-retrieved device fragments); - the initial surgery was not completed with the device; - the event led to a clinically relevant increase in the duration of the surgical procedure (increased time for intervention); - an additional surgery was not required; - a medical intervention was not required; - copies of the operative reports are not available; - copies of the x-ray images are not available; - patient current health condition: "all metal debris could not be recovered.There is a risk of pain in the gluteus medius".(b)(4).
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Manufacturer Narrative
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Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 172200 batch 6426930001 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of 2 devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first breakage complained in regards to this specific device lot.Technical evaluation: the device involved, received on may 2, 2017, was sent to orthofix (b)(4) quality engineering department for the technical evaluation.The returned device was subjected to visual and dimensional check as per orthofix specification.The visual check confirmed the problem notified: the end part of the device is broken.The dimensional check, performed where possible, did not evidence any anomalies.The device was then sent to an external laboratory for the chemical analysis.The results of the technical evaluation confirmed that the device dimensions and the raw material are in compliance to design specification.Medical evaluation: the information made available on the case together with the results of the technical evaluation was sent to our medical evaluator.Please find below an extract of the medical evaluations performed.(b)(6) 2017: "in this case a modular reamer drive shaft 5 mm broke during reaming with a 9.5 mm reamer head into the right femoral shaft of a (b)(6) year old male with an open femoral fracture.It is not clear why this happened, or exactly what happened.The operation was prolonged but the amount of time is not specified.There is a second drive shaft in the reamer tray, and assuming that the reamer was being used with an olive tipped guide wire, removal of the pieces should have been quick and simple.I do not fully understand the remark about pain in the gluteus medius, but i think that it is possible that some fragments of the broken shaft ended up in the surgical wound outside the bone.We need an x-ray of the patient to show us the metal fragments, location and quantity.There is always a risk of this eventuality, especially in the femur of young adult male patients, where the bone is hard.The manual describes how the system should be used.Can we ask if a 9.0 mm reamer had been used prior to the 9.5 mm one? can we also check that the patient received an i/m nail as planned? these drive shafts are designed to be used with all sizes of reamer head up to 17 mm, so it must have been exposed to an excessive load in this patient.So we need to know: · how was the reamer head used? with an olive tipped guide wire? · what order were the reamer heads used in? · where did the breakage occur, inside or outside the bone? · where are the remaining metal fragments? · can we see x-rays of the fragments? · how much delay was incurred as a result of this breakage? · was the intramedullary nailing completed as planned? · what is the current condition of the patient?".May 23, 2017 with the results of the technical evaluation: "this technical report concludes that the exact cause of this breakage is unknown.The end of the reamer shaft broke into 3 separate pieces in addition to the flexible shaft.I note that each of the pieces retains an intact circumference and so would have been retrieved easily with the olive tipped guide wire assuming one was used.However it is possible that a piece broke off that was not circumferential, and would therefore be difficult to retrieve.I note that the breakage was near the cutting head carried by the reamer shaft, and suggest that the breakage should therefore have occurred inside the bone, and therefore there should not have been any pieces in the soft tissues.I still do not understand the remark about pain in the gluteus medius.The cause of the breakage was almost certainly the cutting head jamming on some hard bone and producing a high torque load to the reamer shaft, which then broke into several pieces.This is most likely to happen if the bone is abnormal, or if the reamer heads are not used in the correct order.The story suggests that this was previously normal femoral bone that had a fresh fracture, but the bone was of a (b)(6) year old male, and therefore would have been very hard.We should note the following comments in the instruction for use leaflet, ref.(b)(4): · when an orthofix flexible reamer is used, in the tibia and femur a 3mm diameter 980 mm long olive-tipped guide wire must be inserted first, using an image intensifier to cross a fracture site, and to check that the position of the guide wire is correct when fully inserted.· the width of the isthmus is determined by pre-operative x-ray examination.The instrument with the smallest possible diameter is used for initial reaming of the intramedullary canal.This will usually be 7.0 mm in the humerus, 8.0 mm in the tibia and 9.0 mm in the femur.However individual bones vary and if the chosen reamer will not pass easily a smaller size should be selected.The reamer size should be increased in 0.5 mm steps until the desired size is reached.· the reaming cutter heads must be used in the correct order, at 0.5 mm intervals.Do not use a reaming system if there is a cutting head missing.· it is important to avoid exerting too much pressure during reaming, to avoid the risk of fat embolism.Reaming should be performed with a light touch and gentle forward movement.If this is difficult, remove the reamer head and clean it, and if necessary pass the previous cutting head.· check that the reaming heads are being used in the correct order.· the instrument should not be forced when resistance is encountered, and should always be withdrawn when it is not advancing.If jammed, the reamer can be freed by reversing the reamer driver direction and withdrawing from the canal.Excessive torque and/or stalling of the reamer may cause shaft fracture and fragmentation to occur.· instrument failure or a reduced useful life is more likely to occur with misuse.Small scratches can have a significant effect on the fatigue life or strength of the product.· even with correct use, care and maintenance surgical instruments should not be expected to last indefinitely.This is especially true for cutting instruments (e.G., drills, reamers, taps and rasps) and driving instruments (e.G., mallets, impactors, pins and extractors).Such instruments are subjected to high loads and/or impact forces.Under such conditions breakage can occur, particularly when the instrument is corroded, damaged or scratched.We still need more information as requested to close this case".Final comments: the results of the technical evaluation confirmed that the device dimensions and the raw material are in compliance to design specification.A complete medical evaluation was not performed as some information about the medical procedure and x-rays have not been made available.Orthofix has requested additional information on the event such as how was used the reamer head, where did the breakage occur, where are the remaining metal fragments, copies of the x-rays showing the fragments, quantification of the surgical time delay and patient current health condition.Unfortunately, this information has not been made available.Considering the lack of information provided, it is not possible to draw any conclusion in regards to the complained reamer shaft breakage.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) would like to remind that the instructions for use of the flexible reamer system are included in the leaflet (b)(4).If further information will be received on the event, orthofix (b)(4) will promptly finalize the investigation.Orthofix (b)(4) continues monitoring the devices on the market.
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Event Description
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The information provided by the local distributor indicates: - device code: 172200 (nitinol reamer shafts with ao coupling), - batch number: 6426930001, - quantity: 1.- hospital name: (b)(6) (reference client: (b)(6)).- surgeon's name: not provided (contact: (b)(6).- date of surgery: (b)(6) 2017.- body part to which device was applied: not provided.- surgery description: fracture treatment.- patient information: (b)(6) years, male.- problem observed during: clinical use on patient/intraoperative.- type of problem: device functional problem.- event description: "a reamer diameter 9 mm got broken during surgery.Some parts left in patient body / in a (b)(6) -year-old patient during surgery for a fracture of the tibia and an open fracture of the femur on the right, the orthofix reamer broke inside the patient's femur".The complaint report form also indicates: - the device failure had adverse effects on patient (un-retrieved device fragments).- the initial surgery was not completed with the device.- the event led to a clinically relevant increase in the duration of the surgical procedure (increased time for intervention).- an additional surgery was not required.- a medical intervention was not required.- copies of the operative reports are not available.- copies of the x-ray images are not available.- patient current health condition: "all metal debris could not be recovered.There is a risk of pain in the gluteus medius".(b)(4).
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Manufacturer Narrative
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Analysis of historical records (information already provided).Orthofix srl checked the internal records related to the controls made on the device code 172200 batch (b)(4) before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of 2 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first breakage complained in regards to this specific device lot.Technical evaluation (information already provided): the device involved, received on (b)(4) 2017, was sent to orthofix srl quality engineering department for the technical evaluation.The returned device was subjected to visual and dimensional check as per orthofix specification.The visual check confirmed the problem notified: the end part of the device is broken.The dimensional check, performed where possible, did not evidence any anomalies.The device was then sent to an external laboratory for the chemical analysis.The results of the technical evaluation confirmed that the device dimensions and the raw material are in compliance to design specification.Medical evaluation (new information): the information made available on the case together with the results of the technical evaluation was sent to our medical evaluator.Please find below an extract of the medical evaluations performed.(b)(4) 2017: "in this case a modular reamer drive shaft 5 mm broke during reaming with a 9.5 mm reamer head into the right femoral shaft of a (b)(6) year old male with an open femoral fracture.It is not clear why this happened, or exactly what happened.The operation was prolonged but the amount of time is not specified.There is a second drive shaft in the reamer tray, and assuming that the reamer was being used with an olive tipped guide wire, removal of the pieces should have been quick and simple.I do not fully understand the remark about pain in the gluteus medius, but i think that it is possible that some fragments of the broken shaft ended up in the surgical wound outside the bone.We need an x-ray of the patient to show us the metal fragments, location and quantity.There is always a risk of this eventuality, especially in the femur of young adult male patients, where the bone is hard.The manual describes how the system should be used.Can we ask if a 9.0 mm reamer had been used prior to the 9.5 mm one? can we also check that the patient received an i/m nail as planned? these drive shafts are designed to be used with all sizes of reamer head up to 17 mm, so it must have been exposed to an excessive load in this patient.So we need to know: how was the reamer head used? with an olive tipped guide wire? what order were the reamer heads used in? where did the breakage occur, inside or outside the bone? where are the remaining metal fragments? can we see x-rays of the fragments? how much delay was incurred as a result of this breakage? was the intramedullary nailing completed as planned? what is the current condition of the patient?".(b)(4) 2017 with the results of the technical evaluation: "this technical report concludes that the exact cause of this breakage is unknown.The end of the reamer shaft broke into 3 separate pieces in addition to the flexible shaft.I note that each of the pieces retains an intact circumference and so would have been retrieved easily with the olive tipped guide wire assuming one was used.However it is possible that a piece broke off that was not circumferential, and would therefore be difficult to retrieve.I note that the breakage was near the cutting head carried by the reamer shaft, and suggest that the breakage should therefore have occurred inside the bone, and therefore there should not have been any pieces in the soft tissues.I still do not understand the remark about pain in the gluteus medius.The cause of the breakage was almost certainly the cutting head jamming on some hard bone and producing a high torque load to the reamer shaft, which then broke into several pieces.This is most likely to happen if the bone is abnormal, or if the reamer heads are not used in the correct order.The story suggests that this was previously normal femoral bone that had a fresh fracture, but the bone was of a (b)(6) year old male, and therefore would have been very hard.We should note the following comments in the instruction for use leaflet, ref.Pq frs: when an orthofix flexible reamer is used, in the tibia and femur a 3mm diameter 980 mm long olive-tipped guide wire must be inserted first, using an image intensifier to cross a fracture site, and to check that the position of the guide wire is correct when fully inserted.The width of the isthmus is determined by pre-operative x-ray examination.The instrument with the smallest possible diameter is used for initial reaming of the intramedullary canal.This will usually be 7.0 mm in the humerus, 8.0 mm in the tibia and 9.0 mm in the femur.However individual bones vary and if the chosen reamer will not pass easily a smaller size should be selected.The reamer size should be increased in 0.5 mm steps until the desired size is reached.The reaming cutter heads must be used in the correct order, at 0.5 mm intervals.Do not use a reaming system if there is a cutting head missing.It is important to avoid exerting too much pressure during reaming, to avoid the risk of fat embolism.Reaming should be performed with a light touch and gentle forward movement.If this is difficult, remove the reamer head and clean it, and if necessary pass the previous cutting head.Check that the reaming heads are being used in the correct order.The instrument should not be forced when resistance is encountered, and should always be withdrawn when it is not advancing.If jammed, the reamer can be freed by reversing the reamer driver direction and withdrawing from the canal.Excessive torque and/or stalling of the reamer may cause shaft fracture and fragmentation to occur.Instrument failure or a reduced useful life is more likely to occur with misuse.Small scratches can have a significant effect on the fatigue life or strength of the product.Even with correct use, care and maintenance surgical instruments should not be expected to last indefinitely.This is especially true for cutting instruments (e.G., drills, reamers, taps and rasps) and driving instruments (e.G., mallets, impactors, pins and extractors).Such instruments are subjected to high loads and/or impact forces.Under such conditions breakage can occur, particularly when the instrument is corroded, damaged or scratched.We still need more information as requested to close this case".(b)(4) 2017 with the last information received: "the extra information makes it much clearer what happened.It seems that the flexible reamer was being used as recommended, in the correct order of sizes and with an olive tipped guide wire.The drive shaft just broke suddenly; nearly all of it was retrieved and no remaining parts are visible on x-ray (we are told).The operation continued with the second drive shaft and was completed as planned.These drive shafts can be exposed to large forces and are reused.It is a known risk that they can break, which is the main reason why two are supplied, although this is infrequent.You might consider this normal wear and tear.Considering the amount of use very few break, even in young adult male patients with hard bone".Final comments (new information): the results of the technical evaluation confirmed that the device dimensions and the raw material are in compliance to design specification.The last medical evaluation evidenced as follows: "the extra information makes it much clearer what happened.It seems that the flexible reamer was being used as recommended, in the correct order of sizes and with an olive tipped guide wire.The drive shaft just broke suddenly; nearly all of it was retrieved and no remaining parts are visible on x-ray (we are told).The operation continued with the second drive shaft and was completed as planned.These drive shafts can be exposed to large forces and are reused.It is a known risk that they can break, which is the main reason why two are supplied, although this is infrequent.You might consider this normal wear and tear.Considering the amount of use very few break, even in young adult male patients with hard bone".Based on the results of the technical evaluation and on the evidences deriving from the medical evaluations, orthofix srl can conclude that the problem that occurred is mainly due to normal wear and tear of the device after repeated uses (device manufactured in 2013) in combination with the patient bone characteristics ((b)(6) years old male patient, expected to have hard bone).The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix srl continues monitoring the devices on the market.
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Event Description
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The information initially provided by the local distributor indicates: device code: 172200 (nitinol reamer shafts with ao coupling).Batch number: (b)(4).Quantity: 1.Hospital name: (b)(6).Surgeon's name: not provided (contact: (b)(6).Date of surgery: (b)(6) 2017.Body part to which device was applied: not provided.Surgery description: fracture treatment.Patient information: (b)(6) years, male.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "a reamer diameter 9 mm got broken during surgery.Some parts left in patient body / in a(b)(6) year-old patient during surgery for a fracture of the tibia and an open fracture of the femur on the right, the orthofix reamer broke inside the patient's femur".The complaint report form also indicates: the device failure had adverse effects on patient (un-retrieved device fragments).The initial surgery was not completed with the device.The event led to a clinically relevant increase in the duration of the surgical procedure (increased time for intervention).An additional surgery was not required.A medical intervention was not required.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: "all metal debris could not be recovered.There is a risk of pain in the gluteus medius".On june 23, 2017, orthofix srl received the following additional information: how was the reamer head used? with an olive tipped guide wire? "the reamer head was used with an olive tipped guide wire".What order were the reamer heads used in? "increasing order".Where did the breakage occur, inside or outside the bone? "inside the bone".Where are the remaining metal fragments? "femur".Can we see x-rays of the fragments? "fragments are not visible".How much delay was incurred as a result of this breakage? "difficult to estimate extra time".Was the intramedullary nailing completed as planned? "yes".What is the current condition of the patient? "patient did not come back so far".Manufacturer ref: (b)(4).
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Search Alerts/Recalls
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