Catalog Number 1440-2011 |
Device Problems
Mechanical Problem (1384); Separation Failure (2547); Mechanical Jam (2983)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
|
Event Date 12/29/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that item 1440-2019 and item 1440-2011 wedged together and will not separate.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of the investigation.
|
|
Manufacturer Narrative
|
An event regarding difficulty disassembling the cup impactor bolt from a da cup impactor handle was reported.The event was confirmed.Method & results: -device evaluation and results: no material or manufacturing defects were observed on the returned device.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review found no other similar events have been reported for the subject manufacturing lot.Conclusions: damage to the returned cup impactor handle indicated the handle was rotationally misaligned with the bolt during impaction.The misalignment resulted in deformation of the impactor handle mating feature which caused the reported disassembly difficulty.Material analysis found no evidence of material or manufacturing defects on the returned impactor handle.
|
|
Event Description
|
It was reported that item 1440-2019 and item 1440-2011 wedged together and will not separate.
|
|
Search Alerts/Recalls
|