Catalog Number 2101-0200 |
Device Problems
Break (1069); Crack (1135); Split (2537); Material Integrity Problem (2978)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 09/15/2015 |
Event Type
Injury
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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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Cup impactor broke at shaft/handle.White plastic handle split in three places.At the same timetritanium shell penetrated through medial wall of acetabulum.
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Manufacturer Narrative
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An event regarding fractured handle involving a universal impactor/positioner was reported.The event was confirmed.Method & results: -device evaluation and results: the returned device was in used condition.The visual inspection confirmed the fractured handle.-medical records received and evaluation: no medical records were received.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other similar events reported for this lot.Conclusions: the investigation concluded the handle was cracked due to a design issue.A capa and ecn were issued.An ecn was initiated on apr-2008 for the modification of the radel handle, internal shaft geometry, and strike plate of the universal impactor/postioner, catalog: 2101-0200.The capa was closed and the ecn implemented on 27-oct-2010.
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Event Description
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Cup impactor broke at shaft/handle.White plastic handle split in three places.At the same timetritanium shell penetrated through medial wall of acetabulum.
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Manufacturer Narrative
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A second supplemental report is being submitted on 5/1/2017 to correct the lot code and add the corresponding manufacturing date.
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Event Description
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Cup impactor broke at shaft/handle.White plastic handle split in three places.At the same time tritanium shell penetrated through medial wall of acetabulum.
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Search Alerts/Recalls
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