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Model Number 2107-2200 |
Device Problems
Fracture (1260); Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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It was used to drill the screw not in reverse, the spring part was broken apart.No remnant was found in the body on x-ray, but it is unsure.
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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 via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the outer layer of coils of the flexible shaft have unwound and the coiled wires of the shaft near the tip have fractured.Material analysis: review of the device with a materials analysis engineer indicated that the flexible drill shaft fractured in overload.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been 1 other similar event for the lot referenced also relates to crack/fracture.Conclusions: it was reported that the flexible drill shaft fractured during surgery.Visual inspection of the returned device indicated that the outer layer of coils of the flexible shaft have unwound and the coiled wires of the shaft near the tip have fractured.Review of the device with a materials analysis engineer indicated that the flexible drill shaft fractured in overload.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 becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was used to drill the screw not in reverse, the spring part was broken apart.No remnant was found in the body on x-ray, but it is unsure.
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Search Alerts/Recalls
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