Catalog Number 7205727 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/03/2019 |
Event Type
malfunction
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Event Description
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It was reported that during an ankle arthroscopy the doctor asked for the helicut blade.It was notice that metallic parts were observed when the device started to be used in the osteochondral lesion that the patient presented in the talus.No patient injuries reported.Unknown if there was a delay, if backup was available and how the issue was resolved.No patient injury or other complications were reported.
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Manufacturer Narrative
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Information updated as per information received.
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Event Description
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It was reported that during an ankle arthroscopy the doctor asked for the helicut blade.It was notice that metallic parts were observed when the device started to be used in the osteochondral lesion that the patient presented in the talus.No patient injuries reported.No delay was reported.The procedure was finished with the same device.
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Event Description
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It was reported that during an ankle arthroscopy the doctor asked for the helicut blade.It was notice that metallic parts were observed when the device started to be used in the osteochondral lesion that the patient presented in the talus.No patient injuries reported.No delay was reported.The procedure was finished with the same device.
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Manufacturer Narrative
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One single 7205727 helicut tm blade used for treatment, was returned for evaluation.This product is sold as a shelf carton containing a qty of six blades.They are not to be sold individually.There was a relationship between the reported event and the device.The complaint stated: ¿metallic parts were observed.¿ light scratches on spiral edges and rotational contact were noticed inside the outer blade lumen.The blade spins relatively freely at this time, but does produce a light squeak where the spiral is now making contact with the outer blade.The cause of the surface damage or dings were found to be aligned with inadvertent contact with hard surfaces such as the instrument itself and bone.Bone chip excision may build up from inadequate irrigation.Irrigation may require adjustment and is controlled by the suction pump.Shedding has been found to be consistent with surface damage created from inadvertent excess side loading pressure applied to the device.Per instructions for use precautions: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).This blade has a maximum rotational speed of 5000rpm vs.Other popular blade products that have speeds of up to 10,000rpm.¿ root cause related to the manufacture of the device was not confirmed.Product met specifications upon release to distribution.Complaint history review found no similar reports for this part/lot number.¿.
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Search Alerts/Recalls
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