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Model Number IPN015479 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
Event Type
malfunction
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Event Description
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Mw#5109515.During the spinal procedure, a pin came out of the 3mm kerrison rongeur.An x-ray was performed to rule out retained pin.The pin was then located outside the patient on the sterile field.Staff report that this was the second instance of these k medic kerrison rongeurs losing their pins.Staff also report there were instances of sticking or freezing during use with this instrument set.Fda safety report id#: (b)(4).
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Manufacturer Narrative
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Qn#: (b)(4).The device has not been returned for investigation.
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Event Description
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Mw#5109515 during the spinal procedure, a pin came out of the 3mm kerrison rongeur.An x-ray was performed to rule out retained pin.The pin was then located outside the patient on the sterile field.Staff report that this was the second instance of these k medic kerrison rongeurs losing their pins.Staff also report there were instances of sticking or freezing during use with this instrument set.Fda safety report id# (b)(4).
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Manufacturer Narrative
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Qn# (b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.No photos were provided to support the investigation.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.No confirmed complaints were received in this range with the same issue.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km59316.Root cause not established- no sample provided.The sample will be reinvestigated if received.
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Search Alerts/Recalls
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