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Model Number SABRE, SJ 3.0MM 7CM |
Device Problems
Break (1069); Material Discolored (1170); Excessive Heating (4030)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that the during a tfcc reconstruction, the shaver blade, ar-7300sr, suddenly stopped working.The repair was already completed and the surgeon was using the shaver to clear some debris and some last bits of fraying tissues.The surgeon took the shaver blade out of the patient and immediately noticed that the blade is not working at all despite trying to run the handpiece.When the scrub nurse showed the rep the blade, it looked burnt as the blade had changed color from shiny silver to black-brownish and the tip of the shaver blade had broke off from the inner attachment and was stuck on the mouth of the shaver blade.There were no remnants of the shaver blades left in the patient as confirmed by the surgeon.Additional info to note is that during the procedure, the shaver was set to aggressive mode at 3000rpm.Shaver handpiece, ar-8330h, was used.Surgeon was using a foot pedal to control the shaver.There was a moment when the shaver mode was accidentally changed to forward burr mode at 5600rpm for a couple of seconds and then reverse at 5600rpm for a second.The surgeons tried to change back to the oscillating mode but was having some trouble.The speed should also be 3000rpm.The rep immediately attended to the problem and resolved it.The incident happened after this problem.
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Manufacturer Narrative
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The complaint is not confirmed.While the device was not returned and no pictures were provided, per the event description is concluded that the most likely cause for the event reported is misuse.The information available indicates the device was activated inside the surgical space, but it is unknown if irrigation was used.Due to the small joint space available on wrist arthroscopic procedures, it is probable that the surgeon opted to not utilize irrigation.Activation of the device without irrigation characterizes misuse and may cause overheating.
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Search Alerts/Recalls
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