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The reported event that drill bit axsos 3 ti non-locking, short, ø3.2 x 216mm was alleged of 'component/device stuck' could be confirmed.Based on investigation, the root cause was attributed to be user related.Most likely the bit, while being used/rotated, experienced excessive force, and by accident was bended.Because of this curve, it was difficult to be removed out of the guide.Furthermore, because the bit was stuck inside the drill guide for a long period of time, and because both devices are made out of the same material, forces started to co-exist inside the cannulation of the guide.These resulted in cold welding and corrosion.Based on the investigation, the root cause was attributed to a user related issue.Please keep in mind what the ifu clearly states: the users should ¿always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.¿ furthermore, it is written to ¿only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.¿ the drill bit is bended and consequently it cannot function properly.Also, it is clearly indicated in the ifu that ¿before every operation, to ensure that all devices to be used during the operation function correctly with each other, while during the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure¿.Furthermore, for cannulated instruments, the users should always ¿ensure that bone debris does not accumulate in the cannulation of the instrument.¿ the combination of the bended drill bit with some debris left in the cannulation of the guide, can definitely lead to a jammed situation.Therefore appropriate cleaning and inspection should be performed in order to avoid any of the mentioned situations.According to the cleaning and sterilization guide, ¿the instruments which are supplied in a non-sterile condition must be subjected to an appropriate cleaning and sterilization process before use.[¿] pay particular attention to cannulations and blind holes.[¿] generally un-magnified visual inspection under good light conditions is sufficient.[¿] particular attention should be paid to recessed features (holes, cannulations).Last but not least, ¿stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.¿ however, ¿for multiple use drill bit and cannulated drill bits, it is recommended to use them as single patient devices.¿ 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.The device inspection revealed the following: the device inspection revealed that the drill bit was stuck in the cannulation of the drill guide and could not be removed.The drill presents multiple scratches along ist length, probably because of the attempts of the medical staff to get the drill out.Furthermore, the drill bit was a bit bent in the middle, just in the part where it goes out of the cannulation.For further investigation the two devices were separated in the lab.The drill bit is indeed bent in the middle and the surface that was inside the cannulation is deformed, with signs of discoloration, corrosion and welding.The edges of the helix appear used and deformed, and the tip of the drill is broken.The drill bit also shows a lot of circular scratches along the length that was stuck in the drill guide.Those scratches are the reason only the last three digits of the lot code can be read (64j), which is enough to identify the lot as 04964j since it is the only one for this reference ending with those digits.The drill guide, on the other hand, is in a good general state on the outer parts.After separating the two devices, some small debris can still be noticed on the cannulation, which can partially explain that the two parts got stuck together.A miscroscope inspection of the device showed traces of welding along the length of the cannulation.The drill's diameter was measured, and is equal to 3.15 mm.The drawing states that it should be between 3.1 and 3.2 mm.The diameter of the drill is thus within specifications.The inner diameter of the drill guide was not measured since the drill is stuck in it.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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