Catalog Number 2107-2200 |
Device Problems
Crack (1135); Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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Event Description
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Flexible drill shaft (21072200) snapped while surgeon was drilling 3rd bone screw.Surgeon was unable to complete prep for bone screws as intended.No replacement device available.This led to a ten minute surgical delay.
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Manufacturer Narrative
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Reported event: an event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed by inspection of the returned device.Method & results: device evaluation and results: visual inspection of the returned device noted that the device was returned in used condition.The device is observed to be fractured at one of the end.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional analysis was not performed as the device was returned in fractured condition.Clinician review: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices were accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that flexible drill shaft snapped while surgeon was drilling 3rd bone screw.There was a surgical delay of 10 minutes.Visual inspection of the returned device noted that the device was returned in used condition.The device is observed to be fractured at one of the end.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Flexible drill shaft (21072200) snapped while surgeon was drilling 3rd bone screw.Surgeon was unable to complete prep for bone screws as intended.No replacement device available.This led to a ten minute surgical delay.
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Search Alerts/Recalls
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