Catalog Number 2107-2200 |
Device Problems
Material Deformation (2976); Material Distortion (2977); Material Integrity Problem (2978); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Flexible drill bit attachment from the acetabular screw pan stayed permanently bent at an angle after the small drill bit broke while trying drill for screws.A backup flexible drill bit attachment was used along with a backup drill bit.
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Manufacturer Narrative
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An event regarding damage (flexible drill shaft bent) involving a trident driver shaft was reported.The event was confirmed by visual inspection and material analysis review.Clinician review: not performed because no medical records or x-rays were made available for evaluation.Product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event of bent flexible drill shaft was confirmed by the return of the device.Visual inspection noted the bend in the flexible drill shaft and a material analysis engineer stated, ¿damage observed consistent with contact against a hard object and in-service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿.
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Event Description
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Flexible drill bit attachment from the acetabular screw pan stayed permanently bent at an angle after the small drill bit broke while trying drill for screws.A backup flexible drill bit attachment was used along with a backup drill bit.
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Search Alerts/Recalls
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