STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X360MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 33250360S |
Device Problem
Fracture (1260)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Injury (2348); Ambulation Difficulties (2544); Limb Fracture (4518); Implant Pain (4561)
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Event Date 08/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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The customer reports the following: material breakage without external influence.The patient is announced to us by the neustadt clinic with another periprosthetic femur fracture on the left side.The patient had fallen on the stairs while cleaning at home on (b)(6) 2020 and suffered a subtrochanteric femur fracture on the left side.She was treated as described above on (b)(6) 2020 at the (b)(6) clinic.The intra- and postoperative course was unremarkable.The patient underwent a rehabilitation measure, which also did not show any abnormalities.During the last weeks, increasing complaints on the left side with groin pain developed.For a few days now, the symptoms have been increasing significantly.The patient did not fall again.She has already had problems walking for several weeks, and stress-related pain.In further diagnostics, the peri-implant fracture with of the implanted gamma nail on the left side is shown and the patient is transferred to our clinic.Removal of material and reosteosynthesis using pfn 340/12 in domo.
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Event Description
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The customer reports the following: material breakage without external influence.The patient is announced to us by the (b)(6) clinic with another periprosthetic femur fracture on the left side.The patient had fallen on the stairs while cleaning at home on (b)(6) 2020 and suffered a subtrochanteric femur fracture on the left side.She was treated as described above on (b)(6) 2020 at the (b)(6) clinic.The intra- and postoperative course was unremarkable.The patient underwent a rehabilitation measure, which also did not show any abnormalities.During the last weeks, increasing complaints on the left side with groin pain developed.For a few days now, the symptoms have been increasing significantly.The patient did not fall again.She has already had problems walking for several weeks, and stress-related pain.In further diagnostics, the peri-implant fracture with of the implanted gamma nail on the left side is shown and the patient is transferred to our clinic.Removal of material and reosteosynthesis using pfn 340/12 in domo.Upon receipt of the product, a locking screw was found to be broken.
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Manufacturer Narrative
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The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the anterior web suggests that the nail breakage had its origin in this area.Severe drill marks were found at the lateral entrance of the proximal through hole at the anterior web; they progress through the bore towards medial.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) at the lateral edge of the anterior web.The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest/ waves in both the anterior and posterior web.Starting from the anterior web with an incipient crack at the lateral edge, the breakage progressed through the cross section.Gradually, alongside the anterior web, the posterior web also started getting fatigued and broke ultimately.Severe deformation (plastic deformation) was also observed on the medial side of the through hole at the bearing point of the lag screw, which indicates towards high loading on the nail.Similar features (plastic deformation) were observed on the edges of both the webs, all indicating towards high cyclic loading.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, it can be said that the root cause of the breakage is both user and patient related.Presence of drill marks on the nail indicates towards a user induced cause of failure, while severe deformation at bearing point of lag screw indicates towards high loading (a likelihood of a non-union is also there), which is attributed to a patient related issue.But due to unavailability of critical patient¿s record at the time of evaluation and the fact that there was an intra-op damage of nail, the root cause is determined to be user related, predominantly.The op-tech provides a warning to the user: ¿warning: in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.¿ the ifu specifies: ¿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.¿ if any further information is provided, the complaint report will be updated.
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