STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN EXTRACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 6541-4-804 |
Device Problems
Degraded (1153); Flaked (1246); Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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On (b)(6), myself and one of the sterile processing people noticed that the instruments were starting to chip and flake off.The rubber handles were flaking off, due to so many uses.
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Manufacturer Narrative
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An event regarding santoprene handle degradation was reported.The event was confirmed.Method and results: device evaluation and results: visual analysis confirmed the reported event.The handle was returned degraded.Medical records received and evaluation: not performed because patient factors did not contribute to the reported event.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been one other event for the lot referenced.Conclusions: capa was initiated because a series of complaints were received for triathlon instrumentation where green santoprene over-mold handles have been reported to be degrading, becoming sticky and unstable.This event was determined to be under the scope of the capa.Chemical and cytotoxicity tests showed the degraded santoprene is non-toxic.The ability to clean and sterilize the degraded instruments has not been compromised.
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Event Description
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On (b)(6) myself and one of the sterile processing people noticed that the instruments were starting to chip and flake off.The rubber handles were flaking off, due to so many uses.
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Search Alerts/Recalls
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