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STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 20 HOLE / L414MM; PLATE, FIXATION, BONE
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| Catalog Number 627650S |
| Device Problems
Failure To Adhere Or Bond (1031); Break (1069)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 09/29/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Product disposition unknown.
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Event Description
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The customer reported that the axsos iii plate had broken approximately 6 months after implantation.This had been implanted in a patient with a difficult fracture in whom bone transplantation was required.Non union was reported.
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Event Description
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The customer reported that the axsos iii plate had broken approximately 6 months after implantation.This had been implanted in a patient with a difficult fracture in whom bone transplanation was required.Non union was reported.
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Manufacturer Narrative
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This investigation is revision 2 and is linked with (b)(4), which is the 1st revision.The reported event that an «unk axsos iii plate» broke approximately 6 months after the implantation, could be confirmed, based on the provided surgical procedure and x-rays.Since the actual involved plate was not returned, a visual inspection could not be performed.However, from the provided x-rays it is evident that the plate is broken.As per surgical procedure, the patient had an open distal femoral intra-articular fracture, as a result of a high energy trauma.A plate was implanted in (b)(6) 2016.X-rays from (b)(6) 2016, show a slightly bend plate (outwards).On the (b)(6) 2016, the customer proceeded with bone transplantation.As per surgical procedure: the plan was to use a cable to move the fragment down and fill the gap.By using a system of pulleys, the power can be increased but the speed of travelling will slow down.X-rays from (b)(6) 2016, showed a slightly bent plate (inwards).The fragment was transported for about 6 and a half months, and in (b)(6) 2017, all the transporting metalwork (screw, cable and half pins) was removed.The x-rays showed that the plate is back to its former shape, which indicates that the bending of the plate was caused by the cable.In (b)(6) 2017, the plate was removed and was replaced by another one (the reported plate).This was the 1st revision.X-rays from (b)(6) 2017, showed a slightly bent plate (outwards).X-rays from (b)(6) 2017, showed delayed union.X-rays from (b)(6) 2017, showed incomplete union.X-rays from (b)(6) 2017, showed nonunion, and a visible fracture gap.As per surgical procedure, whilst the docking site is not healing as expected, it was decided to wait for a bit longer as there are no signs of instability of the implant.As per (b)(6) 2017, the patient is walking unaided on shorter distances and with a crutch for longer distances, but is still limping.Further progress with the non-union site was identified.In (b)(6) 2017, approximately 6 months after the implantation, the reported plate was identified broken.From the reported event it is clear that the patient had a difficult fracture which required bone transplantation.After the first revision, and within a period of 6 months, the surgical procedure documented a slightly bent plate, signs of delayed union, signs of incomplete union, signs of nonunion, and a visible fracture gap.All these resulted in a broken plate 6 months later.It is common that adverse results may be clinically related rather than device related.As per ifu ((b)(4)), ¿the most frequent adverse effects involving the use of internal fracture fixation devices are: ¿ delayed union or non-union of the fracture site.¿ these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ shortening of the effected bone/fracture site.¿ according to the surgical reports, the patient presented adverse effects that justify the implants` compromised integrity (delayed union, nonunion).As per ifu ((b)(4)): ¿the use of these devices (plates) provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery.These devices are intended only to assist healing and are not intended to replace normal bone structures.No fracture fixation device that is subject to material fatigue can be expected to withstand activity levels in the same way as would a normal healthy bone.The fracture fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.These implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason, post-operative instructions and warnings to patients are extremely important.External immobilization may be employed until x-rays or other procedures confirm adequate bone consolidation.¿ therefore, the patient should be well informed that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.The last x-ray, from (b)(6) 2017, shows a burst area in the new bone-growth.This gap resulted in insufficient bone support, which indicates that the fracture was not sufficiently healed for the weight bearing which was subjected to.Since the bone was not prepared to support such forces, they were all transmitted to the plate, which, eventually, broke.This is aligned with the fact that the plate is broken in the exact place as the bone.Based on investigation, the root cause would be attributed to a user related issue, due to overload and a delayed union in an unstable fracture.However, please bear in mind that more detailed information about the complaint event as well as the affected devices must be available in order to determine the exact root cause.A review of the device history for the reported lot was not possible because the lot number of the device was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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The customer reported that the axsos iii plate had broken approximately 6 months after implantation.This had been implanted in a patient with a difficult fracture in whom bone transplantation was required.Non union was reported.
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Event Description
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The customer reported that the axsos iii plate had broken approximately 6 months after implantation.This had been implanted in a patient with a difficult fracture in whom bone transplantation was required.Non union was reported.
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Manufacturer Narrative
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This investigation is revision 2 and is linked with (b)(4), which is the 1st revision.The reported event that a distal lateral femur plate axsos 3 ti for right femur 20 hole / l414mm broke approximately 6 months after the implantation, could be confirmed, based on the provided surgical procedure and x-rays, and the received device.The visual inspection revealed that the plate is broken in half (2 separate pieces) and the breakage point is along the 12th round hole.The surface of the plate looks quite scratched - most likely caused during the implantation and/or removed, while the holes have deformed threads.All the broken surfaces present a combination of fibrous and polished areas (most likely due to the continuous friction of the pieces together).One of the broken surfaces, present chevron marks, which point out to the origin of the fracture and indicate that it started at the top edge and progressed across the shaft until the remaining material was no longer strong enough to support the load and it finally broke (instantaneous zone).The two parts can be put back together in good alignment, which indicates a fatigue fracture.Such fractures can occur under repeated or fluctuating stresses.Fatigue fractures begin as a microscopic crack/cracks that grow as force is applied repeatedly to a part.As per surgical procedure, the patient had an open distal femoral intra articular fracture, as a result of a high energy trauma.A plate was implanted in (b)(6) 2016.X-rays from (b)(6) 2016, show a slightly bend plate (outwards).On the (b)(6) 2016, the customer proceeded with bone transplantation.As per surgical procedure: the plan was to use a cable to move the fragment down and fill the gap.By using a system of pulleys, the power can be increased but the speed of traveling will slow down.X-rays from (b)(6) 2016, showed a slightly bent plate (inwards).The fragment was transported for about 6 and a half months, and in (b)(6) 2017, all the transporting metalwork (screw, cable and half pins) was removed.The x-rays showed that the plate is back to its former shape, which indicates that the bending of the plate was caused by the cable.In (b)(6) 2017, the plate was removed and was replaced by another one (the reported plate).This was the 1st revision.X-rays from (b)(6) 2017, showed a slightly bent plate (outwards).X-rays from (b)(6) 2017, showed delayed union.X-rays from (b)(6) 2017, showed incomplete union.X-rays from (b)(6) 2017, showed nonunion, and a visible fracture gap.As per surgical procedure, whilst the docking site is not healing as expected, it was decided to wait for a bit longer as there are no signs of instability of the implant.As per (b)(6) 2017, the patient is walking unaided on shorter distances and with a crutch for longer distances, but is still limping.Further progress with the nonunion site was identified.In (b)(6) 2017, approximately 6 months after the implantation, the reported plate was identified broken.From the reported event it is clear that the patient had a difficult fracture which required bone transplantation.After the first revision, and within a period of 6 months, the surgical procedure documented a slightly bent plate, signs of delayed union, signs of incomplete union, signs of nonunion, and a visible fracture gap.All these resulted in a broken plate 6 months later.It is common that adverse results may be clinically related rather than device related.As per ifu (v15013), ¿the most frequent adverse effects involving the use of internal fracture fixation devices are: ¿ delayed union or nonunion of the fracture site.¿ these devices can break when subjected to the increased loading associated with delayed unions and/or nonunion.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patients¿ activity level will dictate the longevity of the device.¿ conditions attributable to nonunion, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ improper alignment can cause a mal union of the bone and/or bending, cracking or even breakage of the device.¿ shortening of the effected bone/fracture site.¿ according to the surgical reports, the patient presented adverse effects that justify the implants compromised integrity (delayed union, nonunion).As per ifu (v15013): ¿the use of these devices (plates) provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery.These devices are intended only to assist healing and are not intended to replace normal bone structures.No fracture fixation device that is subject to material fatigue can be expected to withstand activity levels in the same way as would a normal healthy bone.The fracture fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.These implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason, postoperative instructions and warnings to patients are extremely important.External immobilization may be employed until x-rays or other procedures confirm adequate bone consolidation.¿ therefore, the patient should be well informed that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.The last x-ray, from (b)(6) 2017, shows a burst area in the new bone growth.This gap resulted in insufficient bone support, which indicates that the fracture was not sufficiently healed for the weight bearing which was subjected to.Since the bone was not prepared to support such forces, they were all transmitted to the plate, which, eventually, broke.This is consistent with the fact that the plate broke at the exact same place as the bone.Based on investigation, the root cause was attributed to a user related issue, due to overload and a delayed union in an unstable fracture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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