STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 IMPACTOR/EXTRACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 6541-7-806 |
Device Problems
Degraded (1153); Residue After Decontamination (2325); Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/19/2016 |
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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Noticed that triathlon mis 4:1impactor/extractor was leaving a blue residue on other insts.
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Manufacturer Narrative
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An event regarding alleged "blue residues" involving a mis 4:1 impactor/extractor was reported.The event was not confirmed.Method & results: device evaluation and results: the santoprene handle coating was degraded.However, the blue residue was not apparent.Device history review indicated all devices accepted into stock met specification.Complaint history review indicated there have been no other events associate with the reported lot.Conclusions: visual inspection of the device showed the santoprene handle coating was degraded.However, the blue residue was not apparent.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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Noticed that triathlon mis 4:1 impactor/extractor was leaving a blue residue on other insts.
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Search Alerts/Recalls
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