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It is reported that a broken k-wire, got stuck in torx t7 screwdriver (with depth gage).Surgeon drilled a k-wire and slide screwdriver with depth gage over the k-wire to measure.User said k-wire was bigger in diameter than normal and got stuck, when user attempted to remove the screwdriver over k-wire it broke while manipulating.They removed the k-wire and used materials from a different company to fulfill surgery.They measured some wires after surgery and allegedly discovered another wire present in hospital with a bigger diameter than 0.91mm.It is reported that the diameter of the k-wires were measured using a digital caliper.One of k-wires has a bigger diameter than.91mm according to customer measurements.Lot numbers are not available.
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The reported incident that screwdriver / depth gauge 2 in 1 autofix 2.0/2.5, 10-30mm was alleged of issue s-36 (component/device stuck) could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate cleaning.Indeed, it was observed that within the cannulation of the screwdriver / depth gauge, in between the k-wire and the inside of the cannulated screwdriver / depth gauge itself, there is an important amount of debris, very likely biological ones.These debris did not allow the k-wire to go through the whole cannulation of the screwdriver / depth gauge during insertion and therefore caused the jam of the k-wire.The surgeon insisted with the insertion and the pressure applied on the k-wire led to deformation and breakage of it.Please note that our cleaning and sterilization guide (l24002000-en rev.N_ot-rg-1_rev-2_ cleaning & sterilization guide_2015-8332) reports the following applicable warnings: ''3.Cleaning, pre-cleaning, procedure ensure that all surfaces are thoroughly wetted, using a syringe to ensure that solution reaches all parts of cannulations etc.Ensure that air is not trapped within features of the device when immersing in the solution.Use a bottle brush of appropriate diameter for cannulations.Ensure that the brush passes the whole length of each cannulation at least three times.Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts.At least three times complete rinsing by application of a syringe (volume 1-50 ml) is required.Visually inspect for any remaining soil and repeat the steps above if necessary.Manual cleaning and disinfection: using suitable brushes (only soft brushes, never metal brushes or steel wool) or cleaning wires (for small channels) clean the device paying particular attention to rough surfaces and features that may be shielded from the brushing action.Additionally, pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts.Rinse cannulations at least three times with a syringe.Rinse for at least 1 min in running water of the specified quality until all traces of cleaning solution are removed.Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts.Rinse cannulations at least three times with a syringe (volume 1-50ml).Disinfection: procedure: rinse cannulations at least three times with a syringe.Rinse for at least 1 min in running water of the specified quality until all traces of disinfectant solution are removed.Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts.Rinse at least five times with a syringe (volume 1-50ml).Automated cleaning and disinfection using washer-disinfector (recommended).Connect cannulations to the rinsing ports of the washer-disinfector.If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket.Arrange medical devices so that cannulations are not horizontal and blind holes incline downwards (to assist drainage).Inspection: before preparing for sterilization, all medical devices should be inspected.Generally un-magnified visual inspection under good light conditions is sufficient.All parts of the devices should be checked for visible soil and/or corrosion.Particular attention should be paid to: recessed features (holes, cannulations).'' 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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It is reported that a broken k-wire, got stuck in torx t7 screwdriver (with depth gage).Surgeon drilled a k-wire and slide screwdriver with depth gage over the k-wire to measure.User said k-wire was bigger in diameter than normal and got stuck, when user attempted to remove the screwdriver over k-wire it broke while manipulating.They removed the k-wire and used materials from a different company to fulfill surgery.They measured some wires after surgery and allegedly discovered another wire present in hospital with a bigger diameter than 0.91mm.It is reported that the diameter of the k-wires were measured using a digital caliper.One of k-wires has a bigger diameter than.91mm according to customer measurements.Lot numbers are not available.
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