Catalog Number RB5964 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2021 |
Event Type
malfunction
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Event Description
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A facility reported that during a case for a back procedure, the screw came off the ultra-coat kerrison micro (rb5964) and fell into the patient.Two different kerrison¿s of the same lot were used.It was reported that the malfunction did not result in patient/user injury or death.No surgical delay was reported.Additional information has been requested.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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Additional b5: it was reported that the staff searched for the screw that fell out of the kerrison.It is unknown whether an x-ray was performed; however, staff confirmed that all broken parts were recovered.A replacement device was available, and the procedure was completed.No adverse event occurred to the patient.The ultra-coat kerrison micro (rb5964) was returned for evaluation: failure analysis: the ultra-coat kerrison was returned in used condition with the set screws in place.Damage due to wear was noted on the set screws.These kerrison may have been reassembled prior to return.Root cause analysis: the complaint reported by the customer was confirmed.The issue of worn set screws may cause them to loosen if not assembled securely before use.No manufacturing, workmanship or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Search Alerts/Recalls
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