Catalog Number 1440-2011 |
Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/11/2015 |
Event Type
malfunction
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Event Description
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The doctor screwed the bolt inserter from the da instrumentation in the trident cup.He used the offset cup impactor from the da instrumentation to impact the cup into the patient.After impacting the cup, he tried to unscrew the bolt from the cup and it would not unscrew.He had to take out the cup, use the other bolt and insert a different cup.
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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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Manufacturer Narrative
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An event regarding difficulty disassembling a da impactor bolt from a shell was reported.The event was not confirmed.Method & results: -device evaluation and results: a function analysis confirmed the reported disassembly difficulty.Inspection of the device found no damage to the product.In addition, no manufacturing non-conformances were identified.-medical records received and evaluation: not performed as patient factors did not contribute to the reported event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no previous reported events for this lot id.Conclusions: it was determined that no manufacturing non-conformities were identified.However, this device is in scope of a non-conformance report to further investigate the root cause of similar reported events.Corrective action/preventive action: an nc was opened on december-2014.All future corrective/preventative actions will be documented in the nc record.
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Event Description
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The doctor screwed the bolt insertor from the da instrumentation in the trident cup.He used the offset cup impactor from the da instrumentation to impact the cup into the patient.After impacting the cup, he tried to unscrew the bolt from the cup and it would not unscrew.He had to take out the cup, use the other bolt and insert a different cup.
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Manufacturer Narrative
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An event regarding difficulty disassembling a da impactor bolt from a shell was reported.The event was not confirmed.Method & results: -device evaluation and results: a function analysis did not confirm the reported disassembly difficulty.Inspection of the device found no damage to the product.In addition, no manufacturing non-conformances were identified.Visual inspection: a visual inspection of the returned device showed no signs of damage on the threads or the device body.Dimensional inspection: not performed as it was confirmed the device is within the scope of nc.Functional inspection: the devices were returned assembled.The bolt and the shell could easily be assembled and disassembled.Therefore, the reported event could not be confirmed.-medical records received and evaluation: not performed as patient factors did not contribute to the reported event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no previous reported events for this lot id.Conclusions: it was determined that no manufacturing non-conformities were identified.However, this device is in scope of a non-conformance report to further investigate the root cause of similar reported events.
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Event Description
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The doctor screwed the bolt insertor from the da instrumentation in the trident cup.He used the offset cup impactor from the da instrumentation to impact the cup into the patient.After impacting the cup, he tried to unscrew the bolt from the cup and it would not unscrew.He had to take out the cup, use the other bolt and insert a different cup.
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Search Alerts/Recalls
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